Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations (RESCUE)
|ClinicalTrials.gov Identifier: NCT01262625|
Recruitment Status : Terminated (Funding timeline completed)
First Posted : December 17, 2010
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Stable Angina Pectoris, CCS Class I to III Angina Equivalent Coronary Artery Disease||Device: CCTA Device: SPECT MPI/ICA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ACRIN 4701 RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2014|
|Study Completion Date :||September 2014|
Experimental: Group A: CCTA Diagnostic
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
Complete diagnostic CCTA per protocol specifications.
Active Comparator: Group B: SPECT MPI/ICA Diagnostic
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
Device: SPECT MPI/ICA
Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
- Outcomes Comparison Between Group A and Group B Diagnostic Tests [ Time Frame: up to 24 Months (depends on time of trial enrollment and funding duration) ]To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of CAD diagnosis (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to OMT.
- Evaluate Prognostic Indices to Predict Outcomes [ Time Frame: 24 Months ]To evaluate the ability of available prognostic indices to predict revascularization or MACE using CCTA information and to develop new indices using the RESCUE trial data.
- Cost, Effectiveness, and Incremental Cost-Effectiveness [ Time Frame: 6 and 12, and possibly 18 and 24 Months ]To determine the cost, effectiveness, and incremental cost-effectiveness of CCTA versus SPECT MPI/ICA in the evaluation of participants with symptoms of stable angina.
- Outcomes Related to Symptoms and Self-Reported Health Status [ Time Frame: 6 and 12, and possibly 18 and 24 Months ]To compare angina symptoms and self-reported health status of participants with symptoms of stable angina undergoing CCTA as initial method of CAD diagnosis to SPECT MPI/ICA as a guide to OMT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262625
|United States, Georgia|
|Atlantic VA Medical Center|
|Decatur, Georgia, United States, 30033|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Virginia|
|Salem VA Medical Center|
|Salem, Virginia, United States, 24153|
|Study Chair:||Arthur Stillman, MD, PhD||Division of Cardiothoracic Imaging, Emory University|
|Principal Investigator:||Pamela K Woodard, MD||Mallinckrodt Institute of Radiology, Washington University of Medicine|