Trial Outcomes & Findings for Stress Testing and Cardiac Magnetic Resonance (NCT NCT00871260)

NCT ID: NCT00871260

Last Updated: 2021-07-12

Results Overview

Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2021-07-12

Participant Flow

Participant milestones

Measure	Healthy Patients Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stress Testing and Cardiac Magnetic Resonance

Baseline characteristics by cohort

Measure	Healthy Patients n=20 Participants Due to low enrollment, twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery. All analyzes were based upon current enrollment.
Age, Continuous	32 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants
Race/Ethnicity, Customized Not Caucasian	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.

Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.

Outcome measures

Measure	Healthy Patients n=20 Participants Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
Major Adverse Cardiovascular Events	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Coronary imaging pulse sequences were unable to be performed. All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.

Relationship between SPECT and CMR results of myocardial perfusion imaging for 1 Year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Coronary imaging were unable to be performed. All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.

Optimization of coronary imaging using CMR for 1 Year

Outcome measures

Outcome data not reported

Adverse Events

Healthy Patients

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Patients n=20 participants at risk Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
Respiratory, thoracic and mediastinal disorders Dyspnea or difficulty with breath	45.0% 9/20 • Number of events 9 • 3 Years Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.
Cardiac disorders Palpitations	35.0% 7/20 • Number of events 7 • 3 Years Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.
Cardiac disorders Chest pressure or heaviness	35.0% 7/20 • Number of events 7 • 3 Years Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.
Cardiac disorders Flushing	25.0% 5/20 • Number of events 5 • 3 Years Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.
Gastrointestinal disorders Dysgeusia immediately following aminophylline administration	10.0% 2/20 • Number of events 2 • 3 Years Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.

Additional Information

Dr. Amit Patel

The University of Chicago

Phone: 773-702-9461

Email: apatel2@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place