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

Cardiac Function Clinical Trial

— Rega Stress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026012
• Other study ID #: HP-00040189
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Function

Intervention

Drug:
• regadenoson
Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.

Locations

Country	Name	City	State
United States	University of MD Cardiology Physicians	Westminster	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.	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)	During and 30 minutes after stress test