Trial Outcomes & Findings for Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging (NCT NCT00857792)

Last Updated: 2016-05-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

3 months

Results posted on

2016-05-11

Participant milestones
Measure	Open Label regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
Overall Study STARTED	120
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	12

Reasons for withdrawal
Measure	Open Label regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
Overall Study inadequate image quality for analysis	12

Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

Baseline characteristics by cohort
Measure	Open Label n=120 Participants regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants

Timeframe: 3 months

Outcome measures
Measure	Open Label n=324 coronary territories regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.	78 % accurately detected perfusion defects

Serious events: 0 serious events

Other events: 82 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Open Label n=120 participants at risk regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
General disorders flushing	44.2% 53/120 • 30 minutes
Respiratory, thoracic and mediastinal disorders dyspnea	35.8% 43/120 • 30 minutes
General disorders chest discomf.	20.0% 24/120 • 30 minutes
General disorders palpitations	16.7% 20/120 • 30 minutes
Gastrointestinal disorders abdominal discomfort	14.2% 17/120 • 30 minutes
General disorders headache	10.8% 13/120 • 30 minutes
General disorders dizziness	6.7% 8/120 • 30 minutes
General disorders nausea	6.7% 8/120 • 30 minutes
General disorders chest pain	5.8% 7/120 • 30 minutes

The University of Chicago Medical Center

Phone: 773-702-7780