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Procedure

Preoperative FFR for Heart 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

Must not have

Women who are pregnant or are seeking to become pregnant

Extra-cardiac illness that is expected to limit survival to less than 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or trying to get pregnant.

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I have a health condition that may limit my life to under 5 years.

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I have had heart bypass surgery or a stent placement in the last 6 months.

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My kidney function is poor, indicated by high creatinine levels.

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I do not have severe heart failure.

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I am scheduled for surgery not related to heart artery blockage treatment.

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I have had serious bleeding issues that could happen again with heart bypass surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation between pre-operative FFR and anastomosis function

Secondary study objectives

Correlation between pre-operative FFR and anastomosis occlusion

Major Adverse Cardiac Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fractional Flow Reserve (FFR)

2015

N/A

~30

0 / 11Eligibility criteria met