Trial Outcomes & Findings for Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing (NCT NCT01026012)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

During and 30 minutes after stress test

Results posted on

2022-08-02

Participant Flow

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

Participant milestones

Participant milestones
Measure	Combined Stress Group 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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Stress Group n=40 Participants patient's were monitor for approximately 30 minutes following regadenoson infusion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	65.9 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: During and 30 minutes after stress test

Population: Subjects whom completed the combined stress test, including imaging

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)

Outcome measures

Outcome measures
Measure	Combined Stress Group n=40 Participants Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.	27 participants

Adverse Events

Safety

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott Jerome

University of Maryland Cardiology

Phone: 410-876-0086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place