PET and Recovery Following Revascularization (PARR 2)

University of Ottawa Heart Institute

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Ventricular Dysfunction, Left

Treatments: Procedure: Positron emission tomography: FDG viability imaging; Other: PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00385242

MCT-37412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

PET guided Therapy

Active Comparator group

Description:

Patients will be randomized to undergo positron emission tomography aspart of their clinical work up

Treatment:

Procedure: Positron emission tomography: FDG viability imaging

Other: PET imaging

Standard care

Active Comparator group

Description:

Patients will be randomized to standard care will under go other types of imaging or work up for revascularization without PET imaging.

Treatment:

Other: PET imaging