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Impact of Preoperative FFR on Arterial Bypass Graft Functionality (IMPAG)

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ClinicalTrials.gov Identifier: NCT02527044
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
David Glineur, Ottawa Heart Institute Research Corporation

Brief Summary:
This study was designed to evaluate the correlation between pre-operative FFR and the functionality of arterial bypass grafts six months after coronary artery bypass grafting. Patients with multi-vessel coronary artery disease will undergo both a coronary angiogram and FFR during their diagnostic workup. All patients will be referred for surgical revascularization (CABG) with planned use of arterial grafts. Six months after surgery, patients will undergo an angiogram to assess the functionality of the bypass graft and anastomosis.

Condition or disease Intervention/treatment Phase
Heart Disease Procedure: Fractional Flow Reserve (FFR) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: FFR values are collected by a member of the research staff. The treating physicians (interventional cardiologist and cardiac surgeon), the patient, and the outcome assessor (interventional cardiologist and cardiac surgeon) will be blinded to the pre-operative FFR values.
Primary Purpose: Treatment
Official Title: Impact of Preoperative FFR on Arterial Bypass Graft Functionality: Towards a New CABG Paradigm
Actual Study Start Date : November 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Treatment: FFR prior to CABG
Patients will undergo a fractional flow reserve prior to their coronary bypass surgery. The results will be blinded from both physician and patients. 6 months after surgery, the investigators will evaluate the impact of preoperative FFR on arterial bypass graft functionality
Procedure: Fractional Flow Reserve (FFR)
An FFR will be performed pre-operative to the CABG procedure




Primary Outcome Measures :
  1. Correlation between pre-operative FFR and anastomosis function [ Time Frame: Up to 12 months ]
    The primary outcome was the evaluation of the correlation between target vessel pre-operative FFR value and the anastomosis function as measured by angiogram approximately 6 months after surgery.


Secondary Outcome Measures :
  1. Correlation between pre-operative FFR and anastomosis occlusion [ Time Frame: Up to 12 months ]
    The evaluation of the correlation between target vessel pre-operative FFR value and occlusion of the anastomosis measured by angiogram approximately 6 months after surgery.

  2. Safety of FFR: Major Adverse Cardiac Events [ Time Frame: Up to 12 months ]
    Major adverse cardiac events (MACE) is a qualitative measurement of any adverse cardiac events such as death or myocardial infraction after the operative procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients with multi-vessel coronary artery disease undergoing elective or urgent first time coronary artery bypass grafting (CABG).
  2. All patients undergoing diagnostic angiography and suspected to have multi-vessel disease for referral to CABG
  3. Patients requiring both on-pump or off-pump CABG are accepted, as long as a arterial revascularisation is planned.
  4. The patients must be over the age of 18.
  5. CABG is the only procedure being conducted

Exclusion Criteria:

  1. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
  2. Redo CABG, or a percutaneous coronary intervention (PCI) within the last 6 months.
  3. Severe renal insufficiency (preoperative creatinine >150umol/L) contraindicating postoperative coronary angiography
  4. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  5. Women who are pregnant or are seeking to become pregnant
  6. Must not have severe congestive heart failure (class III or IV New York Heart Association) at enrollment
  7. Left ventricular ejection fraction less than 30%
  8. Prior history of significant bleeding that might be expected to recur with CABG
  9. Prisoners or institutionalized individuals
  10. Geographic inaccessibility for the follow-up visits required by protocol
  11. Concurrent enrollment in another clinical trial
  12. Extra-cardiac illness that is expected to limit survival to less than 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527044


Contacts
Contact: David Glineur, MD, PhD 613-696-7364 dglineur@ottawaheart.ca
Contact: Jacqueline Fortier, MSc 613-696-7000 ext 18329 jfortier@gmail.com

Locations
Belgium
Clinique Saint-Luc Bouge Completed
Bouge, Belgium
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: David Glineur, MD, PhD    613-696-7364    dglineur@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: David Glineur, MD, PhD Ottawa Heart Institute Research Corporation

Publications:

Responsible Party: David Glineur, Cardiac Surgeon, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02527044     History of Changes
Other Study ID Numbers: 4385
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Glineur, Ottawa Heart Institute Research Corporation:
Coronary Artery Bypass
Flow Reserve

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases