NCT00385242

Brief Summary

Rationale: Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization, but have significant peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population is improves outcome or is cost-effective. Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves LV function, quality of life and is good value for money versus standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

October 6, 2006

Last Update Submit

November 20, 2019

Conditions

Coronary Artery DiseaseVentricular Dysfunction, Left

Keywords

coronary artery diseaseleft ventricular dysfunctionpositron emission tomographyviable myocardiumrevascularizationcost effectiveness

Outcome Measures

Primary Outcomes (1)

  • time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.

    5 years

Secondary Outcomes (1)

  • occurrence of the composite endpoint; individual components of the composite endpoint; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control.

    5 years

Study Arms (2)

PET guided Therapy

ACTIVE COMPARATOR

Patients will be randomized to undergo positron emission tomography aspart of their clinical work up

Procedure: Positron emission tomography: FDG viability imagingOther: PET imaging

Standard care

ACTIVE COMPARATOR

Patients will be randomized to standard care will under go other types of imaging or work up for revascularization without PET imaging.

Other: PET imaging

Interventions

Positron emission tomography: FDG viability imagingPROCEDURE

FDG PET viability imaging

PET guided Therapy
PET imagingOTHER

PET viability imaging

PET guided TherapyStandard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (5)

  • Beanlands RS, Nichol G, Huszti E, Humen D, Racine N, Freeman M, Gulenchyn KY, Garrard L, deKemp R, Guo A, Ruddy TD, Benard F, Lamy A, Iwanochko RM; PARR-2 Investigators. F-18-fluorodeoxyglucose positron emission tomography imaging-assisted management of patients with severe left ventricular dysfunction and suspected coronary disease: a randomized, controlled trial (PARR-2). J Am Coll Cardiol. 2007 Nov 13;50(20):2002-12. doi: 10.1016/j.jacc.2007.09.006. Epub 2007 Oct 10.

    PMID: 17996568BACKGROUND

  • 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; PARR-2 Investigators. Increasing benefit from revascularization is associated with increasing amounts of myocardial hibernation: a substudy of the PARR-2 trial. JACC Cardiovasc Imaging. 2009 Sep;2(9):1060-8. doi: 10.1016/j.jcmg.2009.02.017.

    PMID: 19761983BACKGROUND

  • Abraham A, Nichol G, Williams KA, Guo A, deKemp RA, Garrard L, Davies RA, Duchesne L, Haddad H, Chow B, DaSilva J, Beanlands RS; PARR 2 Investigators. 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 Apr;51(4):567-74. doi: 10.2967/jnumed.109.065938. Epub 2010 Mar 17.

    PMID: 20237039BACKGROUND

  • Shukla T, Nichol G, Wells G, deKemp RA, Davies RA, Haddad H, Duchesne L, Freeman M, Gulenchyn K, Racine N, Humen D, Benard F, Ruddy TD, Chow BJ, DaSilva J, Garrard L, Guo A, Chen L, Beanlands RS. Does FDG PET-assisted management of patients with left ventricular dysfunction improve quality of life? A substudy of the PARR-2 trial. Can J Cardiol. 2012 Jan-Feb;28(1):54-61. doi: 10.1016/j.cjca.2011.09.012. Epub 2011 Dec 3.

    PMID: 22138342BACKGROUND

  • Mc Ardle B, Shukla T, Nichol G, deKemp RA, Bernick J, Guo A, Lim SP, Davies RA, Haddad H, Duchesne L, Hendry P, Masters R, Ross H, Freeman M, Gulenchyn K, Racine N, Humen D, Benard F, Ruddy TD, Chow BJ, Mielniczuk L, DaSilva JN, Garrard L, Wells GA, Beanlands RS; PARR-2 Investigators. Long-Term Follow-Up of Outcomes With F-18-Fluorodeoxyglucose Positron Emission Tomography Imaging-Assisted Management of Patients With Severe Left Ventricular Dysfunction Secondary to Coronary Disease. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004331. doi: 10.1161/CIRCIMAGING.115.004331.

    PMID: 27609816DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseVentricular Dysfunction, Left

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesVentricular Dysfunction

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Rob SB Beanlands, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 9, 2006

Study Start

June 1, 2000

Primary Completion

June 1, 2006

Study Completion

June 1, 2011

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

CA(1)