Preoperative FFR for Heart Disease
(IMPAG Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Glineur, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

I am being considered for heart bypass surgery due to blockages in multiple heart arteries.

I am scheduled for a heart bypass surgery that includes arterial revascularization.

+2 more

Exclusion Criteria

I am currently pregnant or trying to get pregnant.

Left ventricular ejection fraction less than 30%

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

+9 more

Participant Groups

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.

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