Coronary Artery DiseasePhase 3NCT00385242
PET and Recovery Following Revascularization (PARR 2)
A Phase 3 study testing Positron emission tomography: FDG viability imaging and PET imaging in people with Coronary Artery Disease and Ventricular Dysfunction, Left, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ventricular Dysfunction, Left
- What is being tested?
- Positron emission tomography: FDG viability imaging and PET imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2000to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in Left Ventricular Dysfunction (PARR 2)
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.
Read the detailed description
Patients with severe ventricular dysfunction and coronary artery disease have high morbidity and mortality but may benefit from revascularization. However, there is also significant peri-operative morbidity and mortality among these patients. This accounts for the variable approach to these patients in different cardiac centres. Clearly this patient group has the most to gain when coronary revascularization is beneficial, but also the most to lose when it is not helpful. There is a need for an approach that can better define patients with severe ventricular dysfunction due to ischemia, who will be more likely to benefit from revascularization. Positron emission tomography (PET) imaging with F-18-Fluorodeoxyglucose (FDG) has been used to evaluate patients with ventricular dysfunction, to detect ischemic but viable myocardium more likely to recover from revascularization. Recently retrospective studies have shown that FDG PET can identify patients at high risk for cardiac events if they do not undergo revascularization. However, these studies did not evaluate whether FDG PET actually directed therapy decisions and because of their study design, could not determine whether FDG PET altered patient outcome. Our recent studies have shown that FDG PET can have important impact on therapy decisions and that patients with ischemic but viable myocardium are at increased risk. However it remains unclear whether an approach which utilizes FDG PET to define ischemic but viable myocardium can have a beneficial effect on patient outcome. It is also important to consider the potential clinical impact of FDG PET balanced against its limited availability. In addition, despite the cost of the technology, preliminary data from our group and others suggest a potential cost savings. Accordingly, a prospective randomized study is needed to evaluate whether FDG PET directed therapy has a beneficial effect on patient outcome and is cost-effective.
- Being tested
- Positron emission tomography: FDG viability imaging, PET imaging
- Keywords
- coronary artery disease, left ventricular dysfunction, positron emission tomography, viable myocardium, revascularization, cost effectiveness
- Medical subject headings
- Coronary Artery Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography: FDG viability imagingProcedure or surgery
FDG PET viability imaging
PET imagingOther
PET viability imaging
| Study group | Role | What they receive |
|---|---|---|
| PET guided Therapy | Active comparator | Patients will be randomized to undergo positron emission tomography aspart of their clinical work up Receives: Procedure: Positron emission tomography: FDG viability imaging; Other: 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. Receives: Other: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startJun 2000
- Primary completionJun 2006
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Rob Beanlands, Ottawa Heart Institute Research Corporation
- Investigators
- Rob SB Beanlands, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385242
- Sponsor's protocol ID
- MCT-37412
- Status last verified
- Nov 2019
- First submitted
- 6 Oct 2006
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17996568D'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.
PubMed 19761983Abraham 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.
PubMed 20237039Shukla 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.
PubMed 22138342Mc 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.
PubMed 27609816
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in Left Ventricular Dysfunction (PARR 2)
- ClinicalTrials.gov ID
- NCT00385242
- Acronym / sponsor ID
- MCT-37412
- Keywords
- coronary artery disease, left ventricular dysfunction, positron emission tomography, viable myocardium, revascularization, cost effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Study start
- Jun 2000
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with severe ventricular dysfunction and coronary artery disease have high morbidity and mortality but may benefit from revascularization. However, there is also significant peri-operative morbidity and mortality among these patients. This accounts for the variable approach to these patients in different cardiac centres. Clearly this patient group has the most to gain when coronary revascularization is beneficial, but also the most to lose when it is not helpful. There is a need for an approach that can better define patients with severe ventricular dysfunction due to ischemia, who will be more likely to benefit from revascularization. Positron emission tomography (PET) imaging with F-18-Fluorodeoxyglucose (FDG) has been used to evaluate patients with ventricular dysfunction, to detect ischemic but viable myocardium more likely to recover from revascularization. Recently retrospective studies have shown that FDG PET can identify patients at high risk for cardiac events if they do not undergo revascularization. However, these studies did not evaluate whether FDG PET actually directed therapy decisions and because of their study design, could not determine whether FDG PET altered patient outcome. Our recent studies have shown that FDG PET can have important impact on therapy decisions and that patients with ischemic but viable myocardium are at increased risk. However it remains unclear whether an approach which utilizes FDG PET to define ischemic but viable myocardium can have a beneficial effect on patient outcome. It is also important to consider the potential clinical impact of FDG PET balanced against its limited availability. In addition, despite the cost of the technology, preliminary data from our group and others suggest a potential cost savings. Accordingly, a prospective randomized study is needed to evaluate whether FDG PET directed therapy has a beneficial effect on patient outcome and is cost-effective.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET guided Therapy | Active comparator | Procedure: Positron emission tomography: FDG viability imaging, Other: PET imagingPatients will be randomized to undergo positron emission tomography aspart of their clinical work up |
| Standard care | Active comparator | Other: PET imagingPatients will be randomized to standard care will under go other types of imaging or work up for revascularization without PET imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography: FDG viability imagingFDG PET viability imaging | Procedure or surgery | PET guided Therapy |
| PET imagingPET viability imaging | Other | PET guided Therapy, Standard care |
Primary outcome
time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.
Time frame: 5 years
1 secondary outcome
occurrence of the composite endpoint; individual components of the composite endpoint; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 17996568Beanlands 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.
- Background: PubMed 19761983D'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.
- Background: PubMed 20237039Abraham 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.
- Background: PubMed 22138342Shukla 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.
- Derived from this study: PubMed 27609816Mc 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob SB Beanlands, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Positron emission tomography: FDG viability imaging and PET imaging in people with Coronary Artery Disease and Ventricular Dysfunction, Left, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385242, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.