Condition category
Circulatory System
Date applied
22/10/2007
Date assigned
22/10/2007
Last edited
01/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rob Beanlands

ORCID ID

Contact details

University of Ottawa Heart Institute
1st Floor - Director
National Cardiac PET Centre
40 Ruskin Street
Ottawa
Ontario
K1Y 4W7
Canada
+1 613 761 5296
rbeanlands@ottawaheart.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00385242

Protocol/serial number

MCT-37412

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2000

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

430

Participant 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

Recruitment start date

01/05/2000

Recruitment end date

30/06/2004

Locations

Countries of recruitment

Canada

Trial participating centre

University of Ottawa Heart Institute
Ontario
K1Y 4W7
Canada

Sponsor information

Organisation

University of Ottawa Heart Institute (Canada)

Sponsor details

40 Ruskin St
Ottawa
Ontario
K1Y 4W7
Canada
+1 613 761 4699
mfraser@ottawaheart.ca

Sponsor type

University/education

Website

http://www.ottawaheart.ca/UOHI/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-37412)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Heart and Stroke Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

MDS Nordion (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Beanlands R, Nichol G, Ruddy TD, deKemp RA, Hendry P, Humen D, Racine N, Ross H, Benard F, Coates G, Iwanochko RM, Fallen E, Wells G, , Evaluation of outcome and cost-effectiveness using an FDG PET-guided approach to management of patients with coronary disease and severe left ventricular dysfunction (PARR-2): rationale, design, and methods., Control Clin Trials, 2003, 24, 6, 776-794.

  2. Results

    Abraham A, Nichol G, Williams KA, Guo A, deKemp RA, Garrard L, Davies RA, Duchesne L, Haddad H, Chow B, DaSilva J, Beanlands RS, , 18F-FDG PET imaging of myocardial viability in an experienced center with access to 18F-FDG and integration with clinical management teams: the Ottawa-FIVE substudy of the PARR 2 trial., J. Nucl. Med., 2010, 51, 4, 567-574, doi: 10.2967/jnumed.109.065938.

  3. D'Egidio G, Nichol G, Williams KA, Guo A, Garrard L, deKemp R, Ruddy TD, DaSilva J, Humen D, Gulenchyn KY, Freeman M, Racine N, Benard F, Hendry P, Beanlands RS, , Increasing benefit from revascularization is associated with increasing amounts of myocardial hibernation: a substudy of the PARR-2 trial., JACC Cardiovasc Imaging, 2009, 2, 9, 1060-1068, doi: 10.1016/j.jcmg.2009.02.017.

Additional files

Editorial Notes