Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations (RESCUE)
This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into alternate explanations of chest pain, and increased cost-effectiveness in comparison with use of SPECT MPI/invasive coronary angiography (ICA).
Stable Angina Pectoris, CCS Class I to III
Coronary Artery Disease
Device: SPECT MPI/ICA
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||ACRIN 4701 RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations|
- 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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
The Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations (RESCUE) is a multi-center randomized, controlled trial responding to the need for comparative analysis of these imaging technologies and the role of OMT in clinical care. A total of 4300 patients will be randomized to CCTA or SPECT MPI/ICA for diagnostic assessment of angina at up to 80 institutions internationally. This study builds on the results of the COURAGE trial by comparing CCTA and SPECT MPI/ICA integrated into a care paradigm featuring initial treatment with OMT for patients diagnosed with CAD without significant disease in the left main coronary artery. Participants will be followed for a composite endpoint of MACE and cross-over to revascularization over a follow-up period up to two years (two to six time points depending on diagnostic results and time of enrollment into the trial). The primary endpoint of the study is a combined endpoint of occurrence of MACE and revascularization. We will calculate differences in the combined MACE/revascularization endpoint between the CCTA and SPECT MPI/ICA arms. Participant outcomes will be assessed by age, gender, comorbidity, and angina classification class at presentation. Several comparative-effectiveness analyses will be performed. We hypothesize that the CCTA arm will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into or alternate explanations of chest pain, and increased cost-effectiveness in comparison with SPECT MPI/ICA. Findings are expected to result in validation of an evolving new standard of care for patients with stable angina that takes advantage of CCTA and OMT to more cost-effectively drive appropriate care while reducing the need for invasive diagnosis and increased radiation exposure with SPECT MPI/ICA.
|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|