Trial Outcomes & Findings for Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients (NCT NCT01710254)

Results Overview

Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

one MRI, up to 1 hour

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Regadenoson MRI Participants with atrial fibrillation receiving regadenoson stress MRI
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regadenoson MRI n=30 Participants Participants with atrial fibrillation receiving regadenoson stress MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: one MRI, up to 1 hour

Population: Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers

Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

Outcome measures

Outcome measures
Measure	Regadenoson MRI n=26 Participants Participants with atrial fibrillation receiving regadenoson stress MRI
Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)	80 Percentage of true positive cases Interval 30.0 to 99.0

PRIMARY outcome

Timeframe: one MRI, up to 1 hour

Population: Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers

Determination of specificity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

Outcome measures

Outcome measures
Measure	Regadenoson MRI n=26 Participants Participants with atrial fibrillation receiving regadenoson stress MRI
Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)	100 Percentage of true negative cases Interval 81.0 to 100.0

SECONDARY outcome

Timeframe: one MRI, up to 1 hour

Population: Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers

Determination of accuracy of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Accuracy is the percentage of correctly classified subjects (true positive + true negative) among all subjects (true positive + true negative + false positive + false negative). Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

Outcome measures

Outcome measures
Measure	Regadenoson MRI n=26 Participants Participants with atrial fibrillation receiving regadenoson stress MRI
Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)	96 Percentage of correct total cases Interval 78.0 to 100.0

Adverse Events

Regadenoson MRI

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regadenoson MRI n=30 participants at risk Participants with atrial fibrillation receiving regadenoson stress MRI
Respiratory, thoracic and mediastinal disorders Shortness of Breath	26.7% 8/30 • Number of events 8 • Subjects monitored for safety events during the entire magnetic resonance imaging session; up to 1 hour
Respiratory, thoracic and mediastinal disorders Chest Pressure	20.0% 6/30 • Number of events 7 • Subjects monitored for safety events during the entire magnetic resonance imaging session; up to 1 hour
Nervous system disorders Headache	13.3% 4/30 • Number of events 4 • Subjects monitored for safety events during the entire magnetic resonance imaging session; up to 1 hour
Gastrointestinal disorders Nausea	6.7% 2/30 • Number of events 2 • Subjects monitored for safety events during the entire magnetic resonance imaging session; up to 1 hour
Musculoskeletal and connective tissue disorders Jaw Pain	6.7% 2/30 • Number of events 2 • Subjects monitored for safety events during the entire magnetic resonance imaging session; up to 1 hour

Additional Information

Edward DiBella, Ph.D.

University of Utah, Dept. of Radiology Research

Phone: 801-585-5543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place