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Procedure

Fractional Flow Reserve (FFR) for Cardiovascular Disease (IMPAG Trial)

N/A
Waitlist Available
Led By David Glineur, MD, PhD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patients must be over the age of 18
All patients undergoing diagnostic angiography and suspected to have multi-vessel disease for referral to CABG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

IMPAG Trial Summary

This trial is testing whether a diagnostic measurement, FFR, can predict which arterial bypass grafts will still be functioning well 6 months after surgery.

Who is the study for?
This trial is for adults over 18 with multi-vessel coronary artery disease planning to have their first coronary artery bypass grafting (CABG). It's not for pregnant women, those with severe heart failure or poor heart pump function, significant bleeding history, life-limiting extra-cardiac illness, planned non-heart surgeries, severe kidney issues, blood disorders, prisoners, or if they can't follow up.Check my eligibility
What is being tested?
The study tests whether measuring the blood flow pressure in the coronary arteries before surgery (FFR) can predict how well arterial bypass grafts work six months post-CABG. Patients will get a diagnostic angiogram and FFR pre-surgery and another angiogram half a year after to check graft functionality.See study design
What are the potential side effects?
While this trial does not involve medication side effects directly since it focuses on surgical outcomes and diagnostics procedures like angiograms may carry risks such as bleeding at the catheter site, infection risk from invasive procedures.

IMPAG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I am being considered for heart bypass surgery due to blockages in multiple heart arteries.
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I am only having a coronary artery bypass surgery.
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I am having my first CABG surgery for multi-vessel coronary artery disease.

IMPAG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between pre-operative FFR and anastomosis function
Secondary outcome measures
Correlation between pre-operative FFR and anastomosis occlusion
Major Adverse Cardiac Events

IMPAG Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Functional graftExperimental Treatment1 Intervention
Follow-up angiography of all bypass grafts and anastomoses six months after surgery: anastomotic function was scored as 0 for an occluded graft, 1 when the flow from the native coronary artery was dominant, 2 when flow supply from the native coronary and from the graft was balanced, and 3 when the native coronary was fully opacified by the graft. An anastomosis was considered "functional" for score of 3.
Group II: Non functional graftActive Control1 Intervention
Follow-up angiography of all bypass grafts and anastomoses six months after surgery: anastomotic function was scored as 0 for an occluded graft, 1 when the flow from the native coronary artery was dominant, 2 when flow supply from the native coronary and from the graft was balanced, and 3 when the native coronary was fully opacified by the graft. An anastomosis was considered "non functional" for scores of 0 to 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fractional Flow Reserve (FFR)
2015
N/A
~30

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,454 Total Patients Enrolled
David Glineur, MD, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Media Library

Fractional Flow Reserve (FFR) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02527044 — N/A
Cardiovascular Disease Clinical Trial 2023: Fractional Flow Reserve (FFR) Highlights & Side Effects. Trial Name: NCT02527044 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to join this research endeavor?

"According to records on clinicaltrials.gov, applications for this trial are no longer being accepted as it was last updated in January 13th 2022. Nonetheless, there exist 368 other trials which remain open to participants at the moment."

Answered by AI
Recent research and studies
~42 spots leftby Nov 2028