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Completed

NCT Number: NCT00385242

PET and Recovery Following Revascularization (PARR 2)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positron emission tomography: FDG viability imaging

Procedure

FDG PET viability imaging

PET IMAGING

Other

PET viability imaging

Primary outcomes

  1. time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.

    Time frame: 5 years

Secondary outcomes

  1. occurrence of the composite endpoint; individual components of the composite endpoint; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in Left Ventricular Dysfunction (PARR 2)

Important dates

Study start
2000
Primary completion
2006
Study completion
2011
First posted
Oct 9, 2006
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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