Clinical trial NCT03067402: Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline
Official title: Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Coronary Artery Disease
Keywords: Myocardial Infarction
Physiological Stress Test
Nuclear Image Perfusion
Angioplasty
Coronary Artery Bypass Graft
Percutaneous Coronary Intervention
Angina
Ischemia
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Combined index (i.e.if any are positive then index is positive)
timeFrame: Yearly up to 3 years from date of randomization
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline and yearly up to 3 years from date of randomization
Other outcomes:
measure: Resource Utilization
timeFrame: Yearly up to 3 years from date of randomization
Locations:
Study officials:
affiliation: Interventional Cardiologist, Assistant Professor of Medicine, McGill University
name: Dominique Joyal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hendel RC, Berman DS, Di Carli MF, Heidenreich PA, Henkin RE, Pellikka PA, Pohost GM, Williams KA; American College of Cardiology Foundation Appropriate Use Criteria Task Force; American Society of Nuclear Cardiology; American College of Radiology; American Heart Association; American Society of Echocardiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; Society of Nuclear Medicine. ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging: A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the American Society of Nuclear Cardiology, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, and the Society of Nuclear Medicine. J Am Coll Cardiol. 2009 Jun 9;53(23):2201-29. doi: 10.1016/j.jacc.2009.02.013. No abstract available.
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