Trial Information

Ontario Provincial Registry Project for Cardiac Viability Assessment Using FDG PET

Heart failure from reduced left ventricular function is associated with significant
morbidity and mortality and although there have been multiple trials involving medical and
devices therapies that have shown improved survival, the overall mortality remains high.
Therapeutic intervention studies involving transplantation and revascularization concluded
that patients with viable myocardium can be revascularized but this approach is often not
adopted because of high peri-operative morbidity and mortality.

Due to these factors there is a need for a better approach to define and select patients
with severe ventricular dysfunction. FDG PET studies to date have consistently shown that
patients with viable myocardium on FDG PET are at high risk for other cardiac events and
death if they do not undergo timely revascularization. FDG PET viability data has had an
impact on decision making in patients with severe left ventricular (LV) dysfunction and the
benefits of early revascularization have been seen in patients with ischemic viable
myocardium.

The accuracy of FDG PET to predict regional and global LV function recovery, its utility in
decision making and ability to identify high risk patients have all been demonstrated. These
findings all support a clinical role for FDG PET in assessing select patients with CAD and
severe LV function. The Cardiac FDG PET Registry (CADRE) will provide specific information
about the utility of PET in clinical situations. To our knowledge this is the largest
multi-centre FDG PET myocardial viability registry. The registry will facilitate monitoring
of and evaluation of practise patterns, upstream and downstream resource utilization
(diagnostic imaging and revascularization) and outcomes as they relate to the severity of
the abnormalities detected. The impact of FDG PET parameters on outcome measures will be
compared to other clinical parameters. These findings will optimize the implementation of
this technology in clinical practise in Ontario and further identify parameters that with
FDG PET predict adverse outcomes for specific patient populations. The results of this
registry will impact clinical practise and health care for patients in Ontario and
internationally.

3. Research Plan

Objectives:

1. To develop a registry of patients undergoing FDG PET for the assessment of myocardial
viability

2. To determine the upstream and downstream resource utilization (diagnostic imaging and
revascularization) in patients undergoing FDG PET

3. To determine the outcome of patients undergoing PET imaging and relate this outcome to
the severity of the abnormalities detected.

4. To determine the impact of FDG PET parameters on outcome measures compared to other
clinical parameters.

Methods: Consent will be obtained from all eligible subjects. Data will be collected in a
prospective manner to evaluate patients, who meet inclusion criteria, undergoing cardiac PET
imaging. Physicians in Ontario will be notified via the Ontario Medical association (OMA)and
Cardiovascular Care Network that FDG PET viability imaging is clinically available for
appropriate patients through the provincial registry. The participating registry sites as
well as indications for FDG PET viability imaging will be circulated.

Health Canada requires that all patients undergoing imaging with positron emitting
radiopharmaceuticals (PERs) must partake in a research protocol, therefore for those
patients who do not wish to participate in the CADRE study, a second consent is provided for
the collection of baseline safety data only, ie imaging parameters, tracer dose and adverse
effects.