NCT03067402

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Coronary Heart Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Observation	Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years
DIAGNOSTIC_TEST	Nuclear Perfusion Imaging Stress Test	Patient receives routine nuclear image perfusion stress test

Timeline

• Start date: 2017-03-20
• Primary completion: 2021-06-20
• Completion: 2022-06-10
• First posted: 2017-03-01
• Last updated: 2017-03-16