|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00385242 |
|
Date of registration:
|
06/10/2006 |
|
Primary sponsor: |
|
|
Public title:
|
PET and Recovery Following Revascularization (PARR 2)
|
|
Scientific title:
|
PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in LV Dysfunction (PARR 2) |
|
Date of first enrolment:
|
June 2000 |
|
Target sample size:
|
430 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00385242 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Rob SB Beanlands, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Ottawa Heart Institute |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Coronary Artery Disease
|
|
Ventricular Dysfunction, Left
|
|
Intervention(s)
|
|
Other: PET imaging
|
|
Procedure: Positron emission tomography: FDG viability imaging
|
|
Primary Outcome(s)
|
|
the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure. myocardial
[Time Frame: 5 years]
|
|
Secondary Outcome(s)
|
|
time to occurrence of the composite endpoint; individual components of the composite endpoint; ejection fraction; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control.
[Time Frame: 5 years]
|
|
Secondary ID(s)
|
|
MCT-37412
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|