Cardiac FDG PET Viability Registry

NCT00766987 | Completed

• 2 other identifiers: 2007437-01HMOH-06374
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Heart Failure; Ischemic Heart Disease; Myocardial Dysfunction

Keywords

coronary artery disease; FDG PET viability imaging; morbidity and mortality; revascularization; resource utilization

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the composite clinical endpoint of cardiac death, myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.

  1 year

Secondary Outcomes (1)

• Other outcomes will include death from any cause, revascularization, and downstream diagnostic utilization.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for cardiac FDG PET viability imaging

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years of age
• Pregnant or lactating females
• Already known to be ineligible for further revascularization or cardiac transplantation
• Unable to lie supine for imaging with PET
• Unable to take insulin (eg. severe hypokalemia)
• Failure to obtain informed consent
• Claustrophobia.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (4)

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Rob S. Beanlands, MD, FRCP C

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert S. Beanlands, MD, FRCPC, Chief of Cardiology

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 6, 2008
• Study Start: April 1, 2007
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)