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NCT00766987Completed

Cardiac FDG PET Viability Registry

Ontario Provincial Registry Project for Cardiac Viability Assessment Using FDG PET

Source: ClinicalTrials.gov · Last updated 8 May 2024

Brief summary (registry, in English)

Positron Emission Tomography (PET) is a non-invasive, unique nuclear imaging technique that allows the evaluation of blood flow in the heart and provides information about the cell activity of specific organs such as the heart and brain. It also provides useful information for the management of patients with poor pumping function of the heart, heart failure, and coronary artery disease. A cardiac viability imaging looks at how the heart uses glucose (sugar) The imaging process determines areas of the heart that are alive (viable - using sugar) versus areas of the heart that are scar tissue (non-viable). F-18 fluorodeoxyglucose (FDG) is the radioactive substance used to determine myocardial viability. This nuclear imaging technique has been shown to be useful in directing management for patient care. The Ministry of Health recognizes the clinical utility of FDG PET imaging for myocardial viability assessment and other cancer indications. Optimizing the potential advantages of FDG PET in Ontario, will require characterization of the patient population, referral patterns, upstream and downstream resource utilization and patient outcomes. Therefore, registry studies are being undertaken to provide specific information about the utility of PET in these clinical situations in Ontario. The proposed registry will facilitate monitoring of the implementation of this limited technology and allow continued evaluation of practice patterns and outcomes. The University of Ottawa Heart Institute is the coordinating centre for this project with PET centres in London, Hamilton and Toronto also participating. The purpose of this study is to evaluate the utility of FDG PET viability imaging in the decision making process for patients with poor left ventricular function who may be candidates for revascularization and to study the downstream effect of the clinical management decisions. Patients meeting specific inclusion criteria will be eligible for this study.

Status (registry)
Completed
Study type
Observational
Enrollment
2000 (actual)
First submitted
2 Oct 2008
Start date
Apr 2007
Primary completion date
31 Mar 2024
Lead sponsor
Ottawa Heart Institute Research Corporation
NCT number
NCT00766987

What you commit to

  • Study type: Observational
  • Participants enrolled: 2000
  • From Apr 2007 to the primary completion date, 31 Mar 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Already known to be ineligible for further revascularization or cardiac transplantation
  • Failure to obtain informed consent

Age

  • Under 18 years of age

Other

  • Pregnant or lactating females
  • Unable to lie supine for imaging with PET
  • Unable to take insulin (eg. severe hypokalemia)
  • Claustrophobia.

Who the study is looking for

  • Patients with ischemic left ventricular dysfunction in the moderate to severe range (previous assessment of ventricular function with left ventricular ejection fraction (LVEF) approximately 35%
  • Patients will be possible candidates for revascularization if sufficient viable myocardium is identified or considered for heart transplantation if there is no viable myocardium
  • Patients with New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) Class II - IV symptoms despite maximal medical therapy.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hamilton Health Sciences Centre
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
London Health Sciences Centre
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
University of Ottawa Heart Institute
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
University Health Network
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.