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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00827330 |
| ClinicalTrials.gov number | NCT00385242 |
| Secondary identifying numbers | MCT-37412 |
- Submission date
- 22/10/2007
- Registration date
- 22/10/2007
- Last edited
- 01/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rob Beanlands
Scientific
Scientific
University of Ottawa Heart Institute
1st Floor - Director
National Cardiac PET Centre
40 Ruskin Street
Ottawa
Ontario
K1Y 4W7
Canada
| Phone | +1 613 761 5296 |
|---|---|
| rbeanlands@ottawaheart.ca |
Study information
| Study design | Multicentre two arm randomized parallel trial on diagnostic strategy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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) |
| Study acronym | PARR 2 |
| Study objectives | 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. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | Coronary artery disease, LV dysfunction, congestive heart failure |
| Intervention | 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). |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/05/2000 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 430 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Ottawa Heart Institute
Ontario
K1Y 4W7
Canada
K1Y 4W7
Canada
Sponsor information
University of Ottawa Heart Institute (Canada)
University/education
University/education
40 Ruskin St
Ottawa
Ontario
K1Y 4W7
Canada
| Phone | +1 613 761 4699 |
|---|---|
| mfraser@ottawaheart.ca | |
| Website | http://www.ottawaheart.ca/UOHI/ |
"ROR" |
https://ror.org/03c4mmv16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-37412)
No information available
Heart and Stroke Foundation (Canada)
No information available
MDS Nordion (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2003 | Yes | No | |
| Results article | results | 01/09/2009 | Yes | No | |
| Results article | results | 01/04/2010 | Yes | No |
