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

NCT03067402 | Unknown DMC

• 1 other identifier: CODIM-MBM-17-001
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Combined index (i.e.if any are positive then index is positive)

  Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons

  Yearly up to 3 years from date of randomization

Secondary Outcomes (1)

• Quality of Life

  Baseline and yearly up to 3 years from date of randomization

Other Outcomes (1)

• Resource Utilization

  Yearly up to 3 years from date of randomization

Study Arms (2)

Observation

OTHER

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

Nuclear Perfusion Imaging Stress Test

EXPERIMENTAL

Patient receives routine nuclear image perfusion stress test

Diagnostic Test: Nuclear Perfusion Imaging Stress Test

Interventions

Observation OTHER

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

Observation

Nuclear Perfusion Imaging Stress Test DIAGNOSTIC_TEST

Patient receives routine nuclear image perfusion stress test

Nuclear Perfusion Imaging Stress Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone CABG or PCI.
• CABG surgery occurred \>5 years and PCI \>2 years prior to randomization.
• Patients must have had at least one SVG in the CABG group.
• Patients are asymptomatic or have minimal chronic anginal symptoms.

You may not qualify if:

• Participation in a conflicting clinical study.
• RNI testing already planned or performed within the past 12 months.
• Unable to give informed consent.
• Contraindications to or inability to perform exercise treadmill testing or pharmacological testing.
• Medical condition with a prognosis of less than 3.25 years.
• Likely to be unavailable for follow-up.
• Unable to read and understand English or French.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Related Publications (4)

• Brindis RG, Douglas PS, Hendel RC, Peterson ED, Wolk MJ, Allen JM, Patel MR, Raskin IE, Hendel RC, Bateman TM, Cerqueira MD, Gibbons RJ, Gillam LD, Gillespie JA, Hendel RC, Iskandrian AE, Jerome SD, Krumholz HM, Messer JV, Spertus JA, Stowers SA; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Nuclear Cardiology; American Heart Association. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association. J Am Coll Cardiol. 2005 Oct 18;46(8):1587-605. doi: 10.1016/j.jacc.2005.08.029.

  PMID: 16226194 BACKGROUND

• Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.

  PMID: 20177011 BACKGROUND

• 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.

  PMID: 19497454 BACKGROUND

• Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Physicians; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):e44-e164. doi: 10.1016/j.jacc.2012.07.013. Epub 2012 Nov 19. No abstract available.

  PMID: 23182125 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Myocardial Infarction; Angina Pectoris; Ischemia

Interventions

Observation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Dominique Joyal, MD

  Interventional Cardiologist, Assistant Professor of Medicine, McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Iannuzzi, MSc

CONTACT

(514)340-8222; david.iannuzzi.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Assistant Professor of Medicine, McGill University

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: March 20, 2017
• Primary Completion: June 20, 2021
• Study Completion: June 10, 2022
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share