PROMISE: PROspective Multicenter Imaging Study for Evaluation of Chest Pain

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01174550
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 10,003
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 196.1

Study Details

Study Description

Brief Summary

A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain	Procedure: Coronary Angiography; Procedure: Stress Echocardiogram; Procedure: Nuclear Stress Test; Procedure: Exercise Electrocardiogram	N/A

Detailed Description

Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10003 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Functional diagnostic tests Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram	Procedure: Stress Echocardiogram; Use of standard equipment for usual-care testing; Procedure: Nuclear Stress Test; Use of standard equipment for usual-care testing; Procedure: Exercise Electrocardiogram; Use of standard equipment for usual-care testing
Active Comparator: Anatomic diagnostic test Coronary Angiography	Procedure: Coronary Angiography; Use of standard equipment for usual-care testing

Outcome Measures

Primary Outcome Measures

1. Time to Primary Endpoint [90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months]

   Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

Secondary Outcome Measures

1. Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization [90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months]

   Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

2. Time to Death or Myocardial Infarction (MI) [90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months]

   Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

3. Time to Major Complications From Cardiovascular (CV) Procedures [90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months]

   Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

4. Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) [90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months]

   Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

5. Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization [Up to 90 days following participant randomization]

   Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization

6. Medical Cost [90 days and 3 years cumulative]

   Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.

7. Quality of Life (QOL) as Measured by Duke Activity Status Index [Baseline, 6 months, 12 months 24 months]

   Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).

8. Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale [Baseline, 6 month, 12 month, 24 month]

   Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.

9. Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale [Baseline, 6 months, 12 months, 24 months]

   Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.

10. Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing [6 month, 12 month 24 month]

    Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing

11. Cumulative Radiation Exposure Within 90 Days [90 days]

    Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)

• no prior evaluation for this episode of symptoms

• planned non-invasive testing for diagnosis

• men age ≥55 years

• men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia

• women age ≥65 years

• women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia

• Serum creatinine ≤ 1.5 mg/dL within the past 90 days

• Negative urine/serum pregnancy test for female subjects of child-bearing potential

Exclusion Criteria:

• Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)

• Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)

• Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel

• Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months

• Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms

• Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy

• Life expectancy < 2 years

• Unable to provide written informed consent or participate in long-term follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27701

Sponsors and Collaborators

• Duke University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Pamela S Douglas, MD, Duke Clinical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01174550
• Other Study ID Numbers: Pro00019865; R01HL098237-01
• First Posted: Aug 3, 2010
• Last Update Posted: Feb 29, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Duke University: chest pain; coronary artery disease; CAD
• Additional relevant MeSH terms: Chest Pain

Study Results

Participant Flow

Arm/Group Title	Functional Diagnostic Tests	Anatomic Diagnostic Test
Arm/Group Description	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing
Period Title: Overall Study
STARTED	5007	4996
COMPLETED	3737	4123
NOT COMPLETED	1270	873

Baseline Characteristics

Arm/Group Title	Functional Diagnostic Tests	Anatomic Diagnostic Test	Total
Arm/Group Description	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Total of all reporting groups
Overall Participants	5007	4996	10003
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (8.3)	60.7 (8.3)	60.8 (8.3)
Sex: Female, Male (Count of Participants)
Female	2675 53.4%	2595 51.9%	5270 52.7%
Male	2332 46.6%	2401 48.1%	4733 47.3%

Outcome Measures

1. Primary Outcome

Title	Time to Primary Endpoint
Description	Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time Frame	90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
90 days	1.0 0%	1.1 0%
6 months	1.2 0%	1.4 0%
12 months	1.8 0%	1.9 0%
18 months	2.5 0%	2.6 0.1%
24 months	2.9 0.1%	2.8 0.1%
30 months	3.5 0.1%	3.5 0.1%
36 months	4.6 0.1%	3.8 0.1%
42 months	5.3 0.1%	5.1 0.1%

2. Secondary Outcome

Title	Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
Description	Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time Frame	90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
90 day	0.9 0%	1.0 0%
6 month	1.2 0%	1.4 0%
12 month	1.8 0%	1.9 0%
18 month	2.5 0%	2.5 0.1%
24 month	2.9 0.1%	2.8 0.1%
30 month	3.5 0.1%	3.4 0.1%
36 month	4.6 0.1%	3.7 0.1%
42 month	5.2 0.1%	5.1 0.1%

3. Secondary Outcome

Title	Time to Death or Myocardial Infarction (MI)
Description	Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time Frame	90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
90 Days	0.3 0%	0.6 0%
6 months	0.4 0%	0.9 0%
12 months	0.8 0%	1.2 0%
18 months	1.3 0%	1.8 0%
24 months	1.7 0%	2.0 0%
30 months	2.2 0%	2.7 0.1%
36 months	3.3 0.1%	3.0 0.1%
42 months	3.9 0.1%	4.2 0.1%

4. Secondary Outcome

Title	Time to Major Complications From Cardiovascular (CV) Procedures
Description	Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time Frame	90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
90 day	0.1 0%	0.3 0%
6 month	0.2 0%	0.5 0%
12 month	0.5 0%	0.8 0%
18 month	1.0 0%	1.1 0%
24 month	1.2 0%	1.4 0%
30 month	1.7 0%	1.9 0%
36 month	2.6 0.1%	2.2 0%
42 month	3.1 0.1%	3.2 0.1%

5. Secondary Outcome

Title	Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
Description	Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time Frame	90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
90 days	4.4 0.1%	5.2 0.1%
6 months	4.6 0.1%	5.6 0.1%
12 months	5.2 0.1%	6.1 0.1%
18 months	5.9 0.1%	6.7 0.1%
24 months	6.3 0.1%	6.9 0.1%
30 months	6.9 0.1%	7.6 0.2%
36 months	8.0 0.2%	7.9 0.2%
42 months	8.7 0.2%	9.1 0.2%

6. Secondary Outcome

Title	Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
Description	Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Time Frame	Up to 90 days following participant randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
Mean (Standard Error) [Percentage of events]	3.4 (0.3)	4.3 (0.3)

7. Secondary Outcome

Title	Medical Cost
Description	Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Time Frame	90 days and 3 years cumulative

Outcome Measure Data

Analysis Population Description

Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4818	4831
90 days	2494	2240
3 years cumulative	7213	6586

8. Secondary Outcome

Title	Quality of Life (QOL) as Measured by Duke Activity Status Index
Description	Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Time Frame	Baseline, 6 months, 12 months 24 months

Outcome Measure Data

Analysis Population Description

The number of participants were limited due to budget constraints.

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	2982	3003
Baseline	21.5	22.9
6 months	30.5	30.2
12 months	29.2	31.2
24 months	31.5	31.2

9. Secondary Outcome

Title	Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Description	Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Time Frame	Baseline, 6 month, 12 month, 24 month

Outcome Measure Data

Analysis Population Description

The number of participants were limited due to budget constraints.

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	2982	3003
Baseline	70	80
6 month	100	100
12 month	100	100
24 month	100	100

10. Secondary Outcome

Title	Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Description	Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Time Frame	Baseline, 6 months, 12 months, 24 months

Outcome Measure Data

Analysis Population Description

The number of participants were limited due to budget constraints.

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	2982	3003
Baseline	58.3	58.3
6 month	83.3	83.3
12 month	83.3	91.7
24 month	91.7	91.7

11. Secondary Outcome

Title	Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
Description	Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Time Frame	6 month, 12 month 24 month

Outcome Measure Data

Analysis Population Description

The number of participants were limited due to budget constraints.

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	2982	3003
6 months	43.3 0.9%	46.5 0.9%
12 months	47.3 0.9%	48.8 1%
24 months	52.1 1%	54.3 1.1%

12. Secondary Outcome

Title	Cumulative Radiation Exposure Within 90 Days
Description	Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomic Diagnostic Test	Functional Diagnostic Tests
Arm/Group Description	Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing
Measure Participants	4996	5007
Median (Inter-Quartile Range) [milliSievert (mSv)]	10.0	11.3

Adverse Events

Time Frame	Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Adverse Event Reporting Description	Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
Arm/Group Title	Functional Diagnostic Tests		Anatomic Diagnostic Test
Arm/Group Description	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing		Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing
All Cause Mortality
	Functional Diagnostic Tests		Anatomic Diagnostic Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Functional Diagnostic Tests		Anatomic Diagnostic Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	161/5007 (3.2%)		168/4996 (3.4%)
Cardiac disorders
Death- Cardiovascular	21/5007 (0.4%)		14/4996 (0.3%)
Major Bleeding	3/5007 (0.1%)		3/4996 (0.1%)
Myocardial Infarction	40/5007 (0.8%)		30/4996 (0.6%)
Stroke	2/5007 (0%)		1/4996 (0%)
Unstable Angina Hospitalization	41/5007 (0.8%)		61/4996 (1.2%)
General disorders
Death - Non cardiovascular known cause	27/5007 (0.5%)		33/4996 (0.7%)
Death - unknown cause	27/5007 (0.5%)		27/4996 (0.5%)
Other (Not Including Serious) Adverse Events
	Functional Diagnostic Tests		Anatomic Diagnostic Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/5007 (0.3%)		37/4996 (0.7%)
Cardiac disorders
Exercise Induced Hypotension	6/5007 (0.1%)		0/4996 (0%)
Stress Induced Symptoms Related to Functional Testing	4/5007 (0.1%)		0/4996 (0%)
Ventricular Tachycardia	4/5007 (0.1%)		0/4996 (0%)
Hemodynamic Instability	2/5007 (0%)		3/4996 (0.1%)
Any Event Potentially Related to Vasodilators	5/5007 (0.1%)		0/4996 (0%)
General disorders
Hospital Admission Not In The Primary Endpoint	5/5007 (0.1%)		0/4996 (0%)
Skin and subcutaneous tissue disorders
Mild Contrast Reaction (rash or hives)	0/5007 (0%)		22/4996 (0.4%)
Extravasion of Contrast Into Surrounding Tissue	0/5007 (0%)		12/4996 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.