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

Sir Mortimer B. Davis - Jewish General Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Coronary Heart Disease

Treatments: Diagnostic Test: Nuclear Perfusion Imaging Stress Test; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT03067402

CODIM-MBM-17-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Observation

Other group

Description:

Patient receives standard observation, i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years.

Treatment:

Other: Observation

Nuclear Perfusion Imaging Stress Test

Experimental group

Description:

Patient receives routine nuclear image perfusion stress test

Treatment:

Diagnostic Test: Nuclear Perfusion Imaging Stress Test