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Cardiac FDG PET Viability Registry (CADRE)

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ClinicalTrials.gov Identifier: NCT00766987
Recruitment Status : Recruiting
First Posted : October 6, 2008
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Heart Failure Ischemic Heart Disease Myocardial Dysfunction

Detailed Description:

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.


Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ontario Provincial Registry Project for Cardiac Viability Assessment Using FDG PET
Study Start Date : April 2007
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome is the composite clinical endpoint of cardiac death, myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Other outcomes will include death from any cause, revascularization, and downstream diagnostic utilization. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for cardiac FDG PET viability imaging
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766987


Contacts
Contact: Linda M. Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca

Locations
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada
Contact: Karen Gulenchyn, MD         
Principal Investigator: Karen Gulenchyn, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Gerald Wisenberg, MD         
Principal Investigator: Gerald Wisenberg, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Linda Garrard, RN, BScN    613-761-4192    lgarrard@ottawaheart.ca   
Principal Investigator: Rob S Beanlands, MD, FRCP C         
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Robert Iwanochko, MD         
Principal Investigator: Robert Iwanochko, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Rob S. Beanlands, MD, FRCP C Ottawa Heart Institute Research Corporation
More Information

Responsible Party: Rob Beanlands, Robert S. Beanlands, MD, FRCPC, Chief of Cardiology, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT00766987     History of Changes
Other Study ID Numbers: 2007437-01H
MOH-06374
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rob Beanlands, Ottawa Heart Institute Research Corporation:
coronary artery disease
FDG PET viability imaging
morbidity and mortality
revascularization
resource utilization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases