Coronary Artery Disease, Coronary Heart Disease
Conditions
Keywords
Myocardial Infarction, Physiological Stress Test, Nuclear Image Perfusion, Angioplasty, Coronary Artery Bypass Graft, Percutaneous Coronary Intervention, Angina, Ischemia
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.
Interventions
OTHERObservation
Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years
DIAGNOSTIC_TESTNuclear Perfusion Imaging Stress Test
Patient receives routine nuclear image perfusion stress test
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined index (i.e.if any are positive then index is positive) | Yearly up to 3 years from date of randomization | Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Baseline and yearly up to 3 years from date of randomization | Difference in scores between baseline and follow-up Seattle Angina Questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resource Utilization | Yearly up to 3 years from date of randomization | Total number of hospital days for cardiac admissions, further invasive and non-invasive testing, and revascularization procedures |
Contacts
Primary ContactDavid Iannuzzi, MSc
Outcome results
None listed