Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline

Study Overview
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Brief Summary
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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.

Detailed Description
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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? 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? 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? 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.

Official Title
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Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline

Conditions
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Coronary Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Other: Observation
* Diagnostic Test: Nuclear Perfusion Imaging Stress Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patients who have undergone CABG or PCI. 2.CABG surgery occurred >5 years and PCI >2 years prior to randomization. 3.Patients must have had at least one SVG in the CABG group. 4.Patients are asymptomatic or have minimal chronic anginal symptoms. Exclusion Criteria: 1.Participation in a conflicting clinical study. 2.RNI testing already planned or performed within the past 12 months. 3.Unable to give informed consent. 4.Contraindications to or inability to perform exercise treadmill testing or pharmacological testing. 5.Medical condition with a prognosis of less than 3.25 years. 6.Likely to be unavailable for follow-up. 7.Unable to read and understand English or French.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observation<br>Patient receives standard observation, i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years. | Other: Observation<br>* Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years<br>|
| Experimental: Nuclear Perfusion Imaging Stress Test<br>Patient receives routine nuclear image perfusion stress test | Diagnostic Test: Nuclear Perfusion Imaging Stress Test<br>* Patient receives routine nuclear image perfusion stress test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined index (i.e.if any are positive then index is positive) | Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons | Yearly up to 3 years from date of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Difference in scores between baseline and follow-up Seattle Angina Questionnaire | Baseline and yearly up to 3 years from date of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Myocardial Infarction, Physiological Stress Test, Nuclear Image Perfusion, Coronary Artery Bypass Graft, Percutaneous Coronary Intervention, Angina, Ischemia