Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline (ROSSTAR)
Primary Purpose
Coronary Heart Disease, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Observation
Nuclear Perfusion Imaging Stress Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring Myocardial Infarction, Physiological Stress Test, Nuclear Image Perfusion, Angioplasty, Coronary Artery Bypass Graft, Percutaneous Coronary Intervention, Angina, Ischemia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Observation
Nuclear Perfusion Imaging Stress Test
Arm Description
Patient receives standard observation, i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years.
Patient receives routine nuclear image perfusion stress test
Outcomes
Primary Outcome Measures
Combined index (i.e.if any are positive then index is positive)
Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons
Secondary Outcome Measures
Quality of Life
Difference in scores between baseline and follow-up Seattle Angina Questionnaire
Full Information
NCT ID
NCT03067402
First Posted
February 24, 2017
Last Updated
March 15, 2017
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03067402
Brief Title
Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline
Acronym
ROSSTAR
Official Title
Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Anticipated)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
June 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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?
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?
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Other
Arm Description
Patient receives standard observation, i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years.
Arm Title
Nuclear Perfusion Imaging Stress Test
Arm Type
Experimental
Arm Description
Patient receives routine nuclear image perfusion stress test
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years
Intervention Type
Diagnostic Test
Intervention Name(s)
Nuclear Perfusion Imaging Stress Test
Intervention Description
Patient receives routine nuclear image perfusion stress test
Primary Outcome Measure Information:
Title
Combined index (i.e.if any are positive then index is positive)
Description
Myocardial Infarction, Death,Urgent Hospitalization for Cardiac Reasons
Time Frame
Yearly up to 3 years from date of randomization
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Difference in scores between baseline and follow-up Seattle Angina Questionnaire
Time Frame
Baseline and yearly up to 3 years from date of randomization
Other Pre-specified Outcome Measures:
Title
Resource Utilization
Description
Total number of hospital days for cardiac admissions, further invasive and non-invasive testing, and revascularization procedures
Time Frame
Yearly up to 3 years from date of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Iannuzzi, MSc
Phone
(514)340-8222
Ext
26191
Email
david.iannuzzi.ccomtl@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Joyal, MD
Organizational Affiliation
Interventional Cardiologist, Assistant Professor of Medicine, McGill University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16226194
Citation
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. Erratum In: J Am Coll Cardiol. 2005 Dec 6;46(11):2148-50.
Results Reference
background
PubMed Identifier
20177011
Citation
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. Erratum In: Circulation. 2010 Mar 30;121(12):e259.
Results Reference
background
PubMed Identifier
19497454
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.
Results Reference
background
PubMed Identifier
23182125
Citation
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.
Results Reference
background
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Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline
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