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Randomized Investigation of Chest Pain Diagnostic Strategies

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01035047
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
105
Enrollment
1
Location
2
Arms
31
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical decision unit care, coupled with cardiac MRI
 N/A

Detailed Description

Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.

Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.

Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Randomized Investigation of Chest Pain Diagnostic Strategies
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Inpatient Care

This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Experimental: CDU-CMR Protocol

Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.

Other: Clinical decision unit care, coupled with cardiac MRI
After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.

Outcome Measures

Primary Outcome Measures

  1. The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. [Index Hospitalization through 90 days]

Secondary Outcome Measures

  1. Length of Stay [Duration of Index Hospitalization, an average of 1-2 days]

  2. Acute Coronary Syndrome [Index Hospitalization discharge through 90 days]

  3. Mortality [Index Hospitalization through 90 days]

  4. Stress Testing-related Adverse Event [Index Hospitalization through 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age greater than or equal to 21 years of age at the time of enrollment

  • Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation

  • Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS

  • Patient requires an inpatient or CDU evaluation for their chest pain

  • The treating physician feels the patient could be discharged home if cardiac disease was excluded

  • The treating physician feels the patient is safe for CDU care

Pretest probability assessment The assessment of intermediate risk for developing ACS will be based on a TIMI risk score >/= 2 and / or a board certified / board eligible emergency physician clinical impression of intermediate or high likelihood that the symptoms represent ACS. Physicians are encouraged to use the 2007 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines as a framework for this assessment.

Exclusion Criteria:

  • Elevated cardiac biomarkers

  • New ST-segment elevation on any electrocardiogram (>/= 1 mV)

  • New ST-segment depression on any electrocardiogram (>/= 2 mV)

  • Known inducible cardiac ischemia without subsequent revascularization

  • Unable to lie flat

  • Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)

  • Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)

  • Patient refusal or inability to comply with medical record review and follow up

  • Terminal diagnosis with life expectancy less than 3 months

  • Currently Pregnant

  • Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury

  • Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment

  • Hepato-renal syndrome

  • History of liver, heart, or kidney transplant

  • Confirmed angioplasty, stent placement, or coronary artery bypass grafting (CABG) within the last 6 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Chadwick Miller, M.D., WFUBMC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01035047
Other Study ID Numbers:
  • IRB00010410
  • 1R21HL097131-01A1
First Posted:
Dec 18, 2009
Last Update Posted:
Sep 10, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Wake Forest University Health Sciences
Acute Coronary Syndrome
Chest pain
Cardiac MRI
Risk Stratification
Emergency Department
Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain

Study Results

Participant Flow

Recruitment Details Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.
Pre-assignment Detail No participants were excluded from the trial prior to treatment assignment.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Period Title: Overall Study
STARTED 52 53
COMPLETED 52 53
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title CDU-CMR Protocol Inpatient Care Total
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care. Total of all reporting groups
Overall Participants 52 53 105
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
43
82.7%
38
71.7%
81
77.1%
>=65 years
9
17.3%
15
28.3%
24
22.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
54
59
56
Sex: Female, Male (Count of Participants)
Female
24
46.2%
24
45.3%
48
45.7%
Male
28
53.8%
29
54.7%
57
54.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
3.8%
0
0%
2
1.9%
Not Hispanic or Latino
50
96.2%
53
100%
103
98.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
20
38.5%
15
28.3%
35
33.3%
White
30
57.7%
38
71.7%
68
64.8%
More than one race
2
3.8%
0
0%
2
1.9%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
Description
Time Frame Index Hospitalization through 90 days

Outcome Measure Data

Analysis Population Description
Data from all participants was used in the primary outcome analysis.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Measure Participants 52 53
Number [participants]
7
13.5%
20
37.7%
2. Secondary Outcome
Title Length of Stay
Description
Time Frame Duration of Index Hospitalization, an average of 1-2 days

Outcome Measure Data

Analysis Population Description
Data from all participants was used in outcome analysis.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Measure Participants 52 53
Median (Full Range) [hours]
21.1
26.3
3. Secondary Outcome
Title Acute Coronary Syndrome
Description
Time Frame Index Hospitalization discharge through 90 days

Outcome Measure Data

Analysis Population Description
Data from all participants was used in outcome analysis.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Measure Participants 52 53
Number [participants]
0
0%
3
5.7%
4. Secondary Outcome
Title Mortality
Description
Time Frame Index Hospitalization through 90 days

Outcome Measure Data

Analysis Population Description
Data from all participants was used for outcome analysis.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Measure Participants 52 53
Number [participants]
0
0%
0
0%
5. Secondary Outcome
Title Stress Testing-related Adverse Event
Description
Time Frame Index Hospitalization through 90 days

Outcome Measure Data

Analysis Population Description
Data from all participants was used for outcome analysis
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Measure Participants 52 53
Number [participants]
1
1.9%
0
0%

Adverse Events

Time Frame 1 Year
Adverse Event Reporting Description Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
Arm/Group Title CDU-CMR Protocol Inpatient Care
Arm/Group Description Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
All Cause Mortality
CDU-CMR Protocol Inpatient Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
CDU-CMR Protocol Inpatient Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 14/52 (26.9%) 15/53 (28.3%)
Blood and lymphatic system disorders
Admission for angioedema 0/52 (0%) 0 1/53 (1.9%) 1
Cardiac disorders
Readmission for chest pain. 8/52 (15.4%) 15 9/53 (17%) 16
Admission for syncope. 1/52 (1.9%) 1 1/53 (1.9%) 1
Pulseless Electrical Activity (PEA) Arrest 1/52 (1.9%) 1 0/53 (0%) 0
Underwent cardiac magnetic resonance imaging with evolving myocardial infarction 1/52 (1.9%) 1 0/53 (0%) 0
Admission for atrial fibrillation. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for palpitations and wide-complex tachycardia. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for palpitations and atrial flutter with rapid ventricular rate. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for left arm numbness and chest pressure. 0/52 (0%) 0 1/53 (1.9%) 1
Acute coronary syndrome after discharge within 90 days of index. 0/52 (0%) 0 3/53 (5.7%) 3
Endocrine disorders
Admission for severe lactic acidosis secondary to diabetic ketoacidosis (DKA) 0/52 (0%) 0 1/53 (1.9%) 1
Gastrointestinal disorders
Admission for abdominal pain, nausea, vomiting, and diarrhea. 1/52 (1.9%) 1 1/53 (1.9%) 1
Admission for abdominal pain. 1/52 (1.9%) 2 0/53 (0%) 0
Musculoskeletal and connective tissue disorders
Admission for motor vehicle collision (MVC) 2/52 (3.8%) 2 0/53 (0%) 0
Admission for lower extremity pain and suspected septic hip 0/52 (0%) 0 1/53 (1.9%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung biopsy positive for small cell undifferentiated carcinoma 0/52 (0%) 0 1/53 (1.9%) 1
Admission for chemotherapy and radiation therapy 0/52 (0%) 0 1/53 (1.9%) 1
Nervous system disorders
Developed cerebral vascular accident (CVA) after dobutamine stress echocardiogram 0/52 (0%) 0 0/53 (0%) 0
Admission for dizziness 0/52 (0%) 0 1/53 (1.9%) 1
Admission for seizure, altered consciousness, and facial fractures. 0/52 (0%) 0 1/53 (1.9%) 1
Admission for dizziness and presyncopal episodes 0/52 (0%) 0 1/53 (1.9%) 1
Psychiatric disorders
Admission for overdose with suicidal ideation and worsening depression 1/52 (1.9%) 1 0/53 (0%) 0
Involuntary admission for psychiatric illness 0/52 (0%) 0 1/53 (1.9%) 2
Respiratory, thoracic and mediastinal disorders
Admission for dyspnea. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for shortness of breath, dysphagia, and chest pain. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for shortness of breath. 1/52 (1.9%) 1 1/53 (1.9%) 1
Admission for pneumothorax after lung biopsy. 0/52 (0%) 0 1/53 (1.9%) 1
Admission for cough, chest pain, and pain with swallowing 0/52 (0%) 0 1/53 (1.9%) 1
Admission for cough and shortness of breath 0/52 (0%) 0 1/53 (1.9%) 1
Surgical and medical procedures
Admission for laparoscopic radical prostatectomy 1/52 (1.9%) 1 0/53 (0%) 0
Admission for celiac arteriogram and stenting. 1/52 (1.9%) 1 0/53 (0%) 0
Admission for symptomatic cholelithiasis and laparoscopic cholecystectomy. 0/52 (0%) 0 1/53 (1.9%) 1
Other (Not Including Serious) Adverse Events
CDU-CMR Protocol Inpatient Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 18/52 (34.6%) 17/53 (32.1%)
Cardiac disorders
ED visit for chest pain. 3/52 (5.8%) 3 3/53 (5.7%) 3
Early termination of cardiac MRI due to concern for extensive coronary artery disease 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for palpitations 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for chest pain and intoxication 1/52 (1.9%) 1 0/53 (0%) 0
Endocrine disorders
ED visit for abnormal glucose, diabetes, and hypertension 1/52 (1.9%) 1 0/53 (0%) 0
Gastrointestinal disorders
ED visit for abdominal pain, constipation, and chest pain. 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for abdominal pain. 4/52 (7.7%) 4 2/53 (3.8%) 3
ED visit for lower abdominal pain and rectal bleeding 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for abdominal pain, vomiting, and diarrhea 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for vomiting 0/52 (0%) 0 1/53 (1.9%) 1
General disorders
ED visit for high blood pressure 1/52 (1.9%) 1 0/53 (0%) 0
Infections and infestations
ED visit for deep facial abscess. 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for bartholin's gland cyst. 0/52 (0%) 0 1/53 (1.9%) 1
Investigations
Left against medical advice (AMA) from the ED during index hospitalization 0/52 (0%) 0 1/53 (1.9%) 1
Metabolism and nutrition disorders
ED visit for near syncope and mild dehydration 1/52 (1.9%) 1 1/53 (1.9%) 1
Musculoskeletal and connective tissue disorders
ED visit for back pain and rib pain 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for back pain and hip pain 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for left knee injury 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for upper extremity pain 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for 5th metatarsal fracture and abrasion of the right knee 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for knee pain and chest pain. 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for back pain 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for injury to nose and face 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for motor vehicle collision (MVC) 0/52 (0%) 0 1/53 (1.9%) 1
ED visit for lower extremity pain and trouble walking 0/52 (0%) 0 1/53 (1.9%) 1
Nervous system disorders
ED visit for syncopal episode. 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for drainage from navel and facial numbness 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for headache 1/52 (1.9%) 1 0/53 (0%) 0
Psychiatric disorders
ED visit for depression 0/52 (0%) 0 1/53 (1.9%) 1
Renal and urinary disorders
ED visit for urinary frequency 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for urinary frequency, hyperglycemia, and polydypsia 1/52 (1.9%) 1 0/53 (0%) 0
Respiratory, thoracic and mediastinal disorders
ED visit for dyspnea and generalized weakness 1/52 (1.9%) 1 0/53 (0%) 0
ED visit for dyspnea 0/52 (0%) 0 1/53 (1.9%) 1
Social circumstances
ED visit for intoxication 1/52 (1.9%) 1 0/53 (0%) 0
Surgical and medical procedures
Negative exercise stress echocardiogram performed 1/52 (1.9%) 1 0/53 (0%) 0
Vascular disorders
ED visit for weakness and numbness 0/52 (0%) 0 1/53 (1.9%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.

Results Point of Contact

Name/Title Erin Harper
Organization Wake Forest Baptist Medical Center
Phone 336-716-2059
Email erharper@wakehealth.edu
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01035047
Other Study ID Numbers:
  • IRB00010410
  • 1R21HL097131-01A1
First Posted:
Dec 18, 2009
Last Update Posted:
Sep 10, 2018
Last Verified:
Aug 1, 2018