The ROSSTAR trial is a pragmatic trial that will directly compare the strategies of routine and selective stress imaging testing (with radionuclide imaging (RNI)) late after PCI or CABG in asymptomatic patients. The study will be a single center trial based at the Jewish General Hospital (JGH), a McGill University teaching hospital (Montreal, Quebec). A total of 1100 patients who are either \>5 years post-CABG or \>2 years post-PCI will be randomized. Half of the patients will be randomized to a routine RNI testing, and the other half to selective RNI testing.
There is no consensus in current guidelines regarding the role of stress imaging testing late after revascularization. The issue to be resolved by the trial is whether routine stress imaging testing (stress test with nuclear perfusion imaging) benefits patients late after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). What are the principal research questions to be addressed? 1. Is a strategy of routine stress imaging testing late after PCI or CABG associated with lower clinical event rates than a strategy of selective stress imaging testing? 2. Is a strategy of routine stress imaging testing late after PCI or CABG associated with better quality of life than a strategy of selective stress imaging testing? 3. What are the resources utilization associated with routine vs. selective stress imaging testing? What is the primary hypothesis? The primary hypothesis is that routine stress imaging testing late after PCI or CABG is associated with lower clinical event rates than a strategy of selective stress imaging testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,100
Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years
Patient receives routine nuclear image perfusion stress test
Combined index (i.e.if any are positive then index is positive)
Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons
Time frame: Yearly up to 3 years from date of randomization
Quality of Life
Difference in scores between baseline and follow-up Seattle Angina Questionnaire
Time frame: Baseline and yearly up to 3 years from date of randomization
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