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| [ ...Back to search results ] | [ Print-friendly version ] |
| Positron Emission Tomography And Recovery following Revascularization: Outcomes and Cost-Effectiveness using F-18-fluorodeoxyglucose (FDG) PET in Severe Left Ventricular Dysfunction (PARR Phase 2) |
| ISRCTN | ISRCTN00827330 |
| ClinicalTrials.gov identifier | NCT00385242 |
| Public title | Positron Emission Tomography And Recovery following Revascularization: Outcomes and Cost-Effectiveness using F-18-fluorodeoxyglucose (FDG) PET in Severe Left Ventricular Dysfunction (PARR Phase 2) |
| Scientific title | Positron Emission Tomography And Recovery following Revascularization: A Multi Centre, Randomized Trial of Evaluation of Outcome and Cost-Effectiveness using an F-18-fluorodeoxyglucose (FDG) PET-Guided Approach to Management of Patients with Coronary Disease and Severe LV Dysfunction (PARR Phase 2) |
| Acronym | PARR 2 |
| Serial number at source | MCT-37412 |
| Study hypothesis |
1. Therapy guided by by F-18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging achieves a better long-term (5-year) clinical outcome than an approach without PET available ('standard care') for patients with severe LV dysfunction
2. A PET-guided approach to therapy is economically attractive in patients with severe LV dysfunction - determine costs 3. Therapy guided by FDG PET leads to better LV function and quality of life than standard care, in patients with severe LV dysfunction, after long-term follow-up As of 2007, a follow-up study has been approved for funding by the Canadian Institutes of Health Research (CIHR), with the same CIHR grant reference, and with added outcomes. This follow-up study is entitled: 'PET and Recovery following Revascularization (PARR 2) extended follow-up', and all information specifically pertaining to this extended follow-up will be noted under this title. |
| Lay summary | |
| Ethics approval |
Human Research Ethics Committee of the University of Ottawa Heart Institute, Ottawa, Ontario (Canada) approved on the 11th February 1999 (ref: #UOHI-98-148).
Ethics approval for the PET and Recovery following Revascularization (PARR 2) extended follow-up received from the Human Research Ethics Board of the University of Ottawa Heart Institute, Ottawa, Ontario (Canada) on the 29th January 2007 (ref: #UOHI-1998-148). |
| Study design | Multicentre two arm randomized parallel trial on diagnostic strategy |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Coronary artery disease, LV dysfunction, congestive heart failure |
| Participants - inclusion criteria |
1. Age greater than or equal to 18 years, either sex
2. Coronary artery disease documented by coronary angiography, previous myocardial infarction (MI), previous revascularization procedure or positive exercise stress/perfusion imaging 3. Severely reduced LV function with ejection fraction (EF) less than or equal to 35% attributable to coronary disease 4. Any patient being considered for revascularization, transplant/heart failure work up or where in the opinion of the attending physician viability imaging would be considered useful in the ongoing clinical managements |
| Participants - exclusion criteria |
1. Co-morbid medical conditions likely to make survival for the duration of the study unlikely
2. Less than four weeks post MI 3. Not suitable for revascularization before randomization 4. Patients requiring emergency revascularization 5. Lack of informed consent |
| Anticipated start date | 01/05/2000 |
| Anticipated end date | 30/06/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 430 |
| Interventions |
1. FDG PET-guided therapy group:
Patients randomized to this group underwent perfusion and FDG PET imaging within 2 weeks of randomization. When FDG PET identified significant viable myocardium the PET-guided therapy arm recommended: 1.1. Revascularization (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) within 6 weeks if the patient had had angiography, or 1.2. Revascularization work-up if the patient had not had recent angiography When PET did not identify any significant viable myocardium (i.e. predominantly PET scar), the PET-guided therapy arm would recommend no revascularization. The attending physicians were asked to follow the directive of the PET-guided therapy. Patients who did not have a PET scan or had an event before receiving a PET scan were considered as crossovers. 2. Control group: The standard care arm proceeded without PET available. An alternative test for viability could be considered at the physician's discretion. If the clinical status of an enrolled patient changed such that the attending physician would not proceed without PET data, the patient was considered as a crossover. The contact for public and scientific queries for both the original trial and the extended follow-up is Dr Rob Beanlands (contact details can be found below). Please note that the actual start and end dates of the original trial were: Start date: 31/05/2000 End date: 24/06/2004 PET and Recovery following Revascularization (PARR 2) extended follow-up: This extended follow-up has the following start and end dates: Actual start date: 31/05/2000 Anticipated end date: 01/09/2009 As of 08/05/2009 this record was updated to reflect the details of a new sponsor; the initial sponsor at the time of registration was University of Ottawa (Canada). |
| Primary outcome measure(s) |
The occurrence of the composite clinical end point of cardiac death, myocardial infarction, cardiac arrest, transplantation, or re-hospitalization for unstable angina or heart failure (at 1 year).
PET and Recovery following Revascularization (PARR 2) extended follow-up: The same outcomes as above, measured at 5 years. |
| Secondary outcome measure(s) |
Measured at 1 year:
1. Time to occurrence of the composite endpoint 2. Individual components of the composite endpoint 3. Ejection fraction 4. Quality of life 5. Cost and cost-effectiveness of PET-guided therapy versus control PET and Recovery following Revascularization (PARR 2) extended follow-up: Measured every six months up to 5 years: 1. Time to occurrence of the composite endpoint 2. Individual components of the composite endpoint 3. Ejection fraction 4. Quality of life |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-37412)
2. Heart and Stroke Foundation (Canada) 3. MDS Nordion (Canada) |
| Trial website | |
| Publications |
1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14662282
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19761983 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20237039 |
| Contact name | Dr Rob Beanlands |
| Address |
University of Ottawa Heart Institute
1st Floor - Director National Cardiac PET Centre 40 Ruskin Street Ottawa |
| City/town | Ontario |
| Zip/Postcode | K1Y 4W7 |
| Country | Canada |
| Tel | +1 613 761 5296 |
| Fax | +1 613 761 5406 |
| rbeanlands@ottawaheart.ca | |
| Sponsor | University of Ottawa Heart Institute (Canada) |
| Address |
40 Ruskin St
Ottawa |
| City/town | Ontario |
| Zip/Postcode | K1Y 4W7 |
| Country | Canada |
| Tel | +1 613 761 4699 |
| Fax | +1 613 761 5406 |
| mfraser@ottawaheart.ca | |
| Sponsor website: | http://www.ottawaheart.ca/UOHI/ |
| Date applied | 22/10/2007 |
| Last edited | 01/04/2010 |
| Date ISRCTN assigned | 22/10/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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