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

NCT01026012 | Completed Results DMC

• 1 other identifier: HP-00040189
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Function

Keywords

Regadenoson; 85% predicted heart rate; Myocardial perfusion stress testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Combined Protocol

EXPERIMENTAL

patient with submaximal symptom limited maximal exercise testing will also be administered regadenoson pharmacological stress test.

Drug: regadenoson

Interventions

regadenoson DRUG

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

Combined Protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

University of MD Cardiology Physicians

Westminster, Maryland, 21157, United States

Location

MeSH Terms

Interventions

regadenoson

Results Point of Contact

• Title: Dr. Scott Jerome
• Organization: University of Maryland Cardiology

sjerome@medicine.umaryland.edu

410-876-0086

Study Officials

• Scott Jerome, D.O.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Director of Ambulatory Outreach Cardiology

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 2, 2022
• Results First Posted: December 19, 2014

Record last verified: 2022-07

Locations

US (1)