PET and Recovery Following Revascularization (PARR 2)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Rob Beanlands, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00385242
First received: October 6, 2006
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

Rationale: Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization, but have significant peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population is improves outcome or is cost-effective.

Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves LV function, quality of life and is good value for money versus standard care.


Condition Intervention Phase
Coronary Artery Disease
Ventricular Dysfunction, Left
Procedure: Positron emission tomography: FDG viability imaging
Other: PET imaging
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in LV Dysfunction (PARR 2)

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure. myocardial [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to occurrence of the composite endpoint; individual components of the composite endpoint; ejection fraction; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 430
Study Start Date: June 2000
Study Completion Date: June 2011
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PET guided Therapy
Patients will be randomized to undergo positron emission tomography aspart of their clinical work up
Procedure: Positron emission tomography: FDG viability imaging
FDG PET viability imaging
Other: PET imaging
PET viability imaging
Active Comparator: Standard care
Patients will be randomized to standard care will under go other types of imaging or work up for revascularization without PET imaging.
Other: PET imaging
PET viability imaging

Detailed Description:

Patients with severe ventricular dysfunction and coronary artery disease have high morbidity and mortality but may benefit from revascularization. However, there is also significant peri-operative morbidity and mortality among these patients. This accounts for the variable approach to these patients in different cardiac centres. Clearly this patient group has the most to gain when coronary revascularization is beneficial, but also the most to lose when it is not helpful. There is a need for an approach that can better define patients with severe ventricular dysfunction due to ischemia, who will be more likely to benefit from revascularization. Positron emission tomography (PET) imaging with F-18-Fluorodeoxyglucose (FDG) has been used to evaluate patients with ventricular dysfunction, to detect ischemic but viable myocardium more likely to recover from revascularization. Recently retrospective studies have shown that FDG PET can identify patients at high risk for cardiac events if they do not undergo revascularization. However, these studies did not evaluate whether FDG PET actually directed therapy decisions and because of their study design, could not determine whether FDG PET altered patient outcome. Our recent studies have shown that FDG PET can have important impact on therapy decisions and that patients with ischemic but viable myocardium are at increased risk. However it remains unclear whether an approach which utilizes FDG PET to define ischemic but viable myocardium can have a beneficial effect on patient outcome. It is also important to consider the potential clinical impact of FDG PET balanced against its limited availability. In addition, despite the cost of the technology, preliminary data from our group and others suggest a potential cost savings. Accordingly, a prospective randomized study is needed to evaluate whether FDG PET directed therapy has a beneficial effect on patient outcome and is cost-effective.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is > 18 years of age.
  • Documented ejection fraction of <35% attributable to CAD.
  • Documented CAD
  • Any patient being considered for revascularization, transplant/heart failure work up or where, in the opinion of the attending physician or surgeon, viability imaging would be considered useful in ongoing clinical management decisions.

Exclusion Criteria:

  • Other co-morbid conditions making survival unlikely
  • < 6 weeks post myocardial infarction
  • CAD unsuitable for revascularization
  • emergency revascularization is required.
  • severe valvular disease that requires surgery.
  • Geographically inaccessible
  • Lack of informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385242

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Rob SB Beanlands, MD University of Ottawa Heart Institute
  More Information

No publications provided by University of Ottawa Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00385242     History of Changes
Other Study ID Numbers: MCT-37412
Study First Received: October 6, 2006
Last Updated: July 12, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
coronary artery disease
left ventricular dysfunction
positron emission tomography
viable myocardium
revascularization
cost effectiveness

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014