Rega Stress: Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01026012
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

It is been known for at least 20 years that the hemodynamic data, the amount of exercise performed as well as symptoms on the treadmill, has significant value to the perfusion stress testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6 minutes), this hemodynamic data is lost. Because of this loss of valuable data, it is felt that there is also a loss of significant prognostic data as well. With the advent and FDA release of Regadenoson in a rapid injection form (over 10 seconds), it is thought that the combination of both exercise stress testing and pharmacologic testing in subjects that do not achieve 85% in a maximal predicted heart rate may be a viable stress testing option.

The purpose of this study is to look at using the drug, regadenoson, with exercise stress testing; and the side effect symptoms that may be experienced by individual subjects using this combination.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Function	Drug: regadenoson	N/A

Detailed Description

A nuclear stress test has been recommended for a patient by their doctor. This test helps to detect significant blockages in the artery to the heart. The test involves the patient walking on a treadmill until their heart rate reaches 85% of their age-determined maximal predicted heart rate. If the patient needs to stop walking for any reason (tiredness, chest pain, shortness of breath or dizziness) prior to reaching the 85% of their maximal heart rate, then the test becomes inaccurate and blockages can be missed. Nonetheless, the information that we gain from the patient walking remains valuable.

If the subject does not reach 85%, the usual procedure is to re-do the test where the subject would not walk on the treadmill, but would be injected with a pharmacologic agent (drug) which dilates their blood vessels. This would allow us to obtain an accurate picture about any blockages in the blood vessels. By doing the "drug" test alone, we lose the important information gained by the treadmill test.

In the present study the subject will be asked to walk on the treadmill and near the end of the walk, if they do not reach 85%, then the "drug" will be given to the patient. Regadenoson is FDA approved for drug stress testing. Regadenoson (versus one of the other pharmacological agents) will be given at a dose of 400 mcg, will be infused over 10 - 20 seconds followed by standard flushing solution, and then the infusion of a radiotracer (the FDA approved method of administration) will be given for nuclear imaging. The entire intravenous procedure takes 30 seconds. The subject will then undergo 5 minutes of standard observation/monitoring post infusion administration. Standard nuclear stress imaging will then follow. By doing this, we will obtain all the important information from the exercise portion of this test and maintain the accuracy to detect blockages. By doing the study in this manner, we will be able to save the subject time and obtain more information about the heart than either test individually.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined Protocol patient with submaximal symptom limited maximal exercise testing will also be administered regadenoson pharmacological stress test.	Drug: regadenoson; Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others. [During and 30 minutes after stress test]

   Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Referred for clinically indicated exercise stress Myocardial Perfusion Imaging (MPI) study, Provide written informed consent

2. Provide written informed consent

Exclusion Criteria:

1. Acute myocardial infarction or unstable angina within three months 2 Any condition judged by the investigator likely to pose a safety risk to the patient 3 Participation in another investigational drug study within one month, Or participation in any previous rate adenosine trial 4 Females who are breast-feeding or pregnant 5 Dipyridamole use within 48 hours 6 Consumption of methyl xanthine's, coffee theophylline, caffeinated soft drinks chocolate within 24 hours of the stress test 7 Has received a heart transplant 8 Has a recent history (less than 30 days) of uncontrolled ventricular arrythmia 9 Active respiratory wheezing, angina, ventricular dysrhythmia, low blood pressure or EKG changes 10 Patients that do not have a functioning artificial pacemaker and have either: 1) second or third degree atrialventicular block 2) sinus node dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of MD Cardiology Physicians	Westminster	Maryland	United States	21157

Sponsors and Collaborators

• University of Maryland, Baltimore
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Scott Jerome, D.O., University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scott Jerome, Assistant Professor of Medicine, Director of Ambulatory Outreach Cardiology, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01026012
• Other Study ID Numbers: HP-00040189
• First Posted: Dec 4, 2009
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Scott Jerome, Assistant Professor of Medicine, Director of Ambulatory Outreach Cardiology, University of Maryland, Baltimore: Regadenoson; 85% predicted heart rate; Myocardial perfusion stress testing
• Additional relevant MeSH terms: Regadenoson

Study Results

Participant Flow

Recruitment Details	recruitment period January 2010 to October 2010 occurred in outpatient office.

Arm/Group Title	Combined Stress Group
Arm/Group Description	Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Combined Stress Group
Arm/Group Description	patient's were monitor for approximately 30 minutes following regadenoson infusion
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 47.5%
>=65 years	21 52.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (1)
Sex: Female, Male (Count of Participants)
Female	12 30%
Male	28 70%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.
Description	Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)
Time Frame	During and 30 minutes after stress test

Outcome Measure Data

Analysis Population Description

Subjects whom completed the combined stress test, including imaging

Arm/Group Title	Combined Stress Group
Arm/Group Description	Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
Measure Participants	40
Number [participants]	27 67.5%

Adverse Events

Arm/Group Title	Safety
Arm/Group Description	patient's were monitor for approximately 30 minutes following regadenoson infusion
All Cause Mortality
	Safety
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Safety
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Safety
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

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.