Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations (RESCUE)
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|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|
|Actual Primary Completion Date :||September 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|