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

March 15, 2017 updated by: Dr. Dominique Joyal, Sir Mortimer B. Davis - Jewish General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
Experimental: Nuclear Perfusion Imaging Stress Test
Patient receives routine nuclear image perfusion stress test
Diagnostic test: Nuclear Perfusion Imaging Stress Test
Patient receives routine nuclear image perfusion stress test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined index (i.e.if any are positive then index is positive)
Time Frame: Yearly up to 3 years from date of randomization
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
Time Frame: Baseline and yearly up to 3 years from date of randomization
Difference in scores between baseline and follow-up Seattle Angina Questionnaire
Baseline and yearly up to 3 years from date of randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resource Utilization
Time Frame: 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
Yearly up to 3 years from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

  • Principal Investigator: Dominique Joyal, MD, Interventional Cardiologist, Assistant Professor of Medicine, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2017

Primary Completion (Anticipated)

June 20, 2021

Study Completion (Anticipated)

June 10, 2022

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODIM-MBM-17-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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