Preoperative FFR for Heart Disease

(IMPAG Trial)

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Pregnancy, Severe heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Fractional Flow Reserve (FFR) can predict the success of heart bypass surgery for individuals with multi-vessel coronary artery disease. The researchers aim to determine if FFR measurements taken before surgery correlate with the effectiveness of bypass grafts six months later. Participants will undergo FFR measurements along with their usual heart tests before surgery and another test six months after to assess the grafts. Ideal participants are those diagnosed with multi-vessel coronary artery disease and scheduled for their first coronary artery bypass surgery. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future heart bypass outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Fractional Flow Reserve (FFR) is safe for use in preoperative assessments?

Research has shown that using Fractional Flow Reserve (FFR) to guide treatment in heart patients is generally safe. In one study, patients who underwent FFR measurements did not experience more major heart problems over time compared to others. Another study found that using FFR was linked to lower death rates one year later in patients with stable heart disease. Although some reports noted a higher risk of heart issues when FFR results were borderline, FFR remains a safe method for assessing heart arteries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Fractional Flow Reserve (FFR) in heart disease treatment because it offers a more precise way to assess the need for bypass surgery. Unlike traditional methods that rely on imaging alone, FFR measures blood flow pressure differences to determine the severity of coronary artery blockages. This approach could lead to more accurate surgical decisions, potentially improving outcomes by ensuring that only truly necessary procedures are performed. Additionally, assessing graft functionality through clear scoring (0 to 3) post-surgery helps in evaluating the success of the bypass, offering a clearer picture of surgical efficacy.

What evidence suggests that Fractional Flow Reserve (FFR) is effective for heart disease?

This trial will compare the use of Fractional Flow Reserve (FFR) in assessing the functionality of bypass grafts. Studies have shown that FFR is a useful tool for managing heart conditions. FFR measures the pressure difference across a blocked heart artery to help determine if a procedure is necessary. Guiding heart procedures with FFR can reduce the risk of future heart issues. Research indicates that procedures guided by FFR result in fewer blockages compared to those guided only by angiography, an X-ray test for viewing blood vessels. Overall, FFR is considered safe and effective for improving heart health in patients with coronary artery disease. ^{6 7 8 9 10}

Who Is on the Research Team?

David Glineur, MD, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Assessment

Patients undergo coronary angiogram and FFR during their diagnostic workup

1-2 weeks

1 visit (in-person)

Surgical Revascularization

Patients undergo coronary artery bypass grafting (CABG) with planned use of arterial grafts

1 week

1 visit (in-patient)

Follow-up

Six months after surgery, patients undergo an angiogram to assess the functionality of the bypass graft and anastomosis

6 months

1 visit (in-person)

Long-term Follow-up

Participants are monitored for major adverse cardiac events (MACE) up to 12 months after surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Flow Reserve (FFR)

Trial Overview 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.

How Is the Trial Designed?

Group I: Functional graft Experimental Treatment 1 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 graft Active Control 1 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.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6649528/

Fractional Flow Reserve: An Updated Review - PMC Fractional flow reserve (FFR) has emerged as a useful tool to determine the lesions that require revascularization.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.034552

Agreement of Fractional Flow Reserve Estimated by ... FFR‐CT can also identify hemodynamically significant coronary artery disease when FFR‐CT is <0.49 with 90% accuracy.

3. withpower.com withpower.com/trial/phase-heart-diseases-10-2015-9865b

Preoperative FFR for Heart Disease (IMPAG Trial) Studies have shown that using Fractional Flow Reserve (FFR) to guide heart procedures is generally safe and can help reduce the risk of future heart problems.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2024/12130/clinical_value_of_fractional_flow_reserve_in.48.aspx

Clinical value of fractional flow reserve in coronary heart .. ... This study aims to assess the clinical significance of CAG combined with FFR for the treatment of CHD with coronary artery stenosis exceeding 70%.

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1348341/full

Fractional flow reserve and instantaneous wave-free ratio ... Summarising their outcome data, the authors report significantly reduced occlusion rates with FFR-guided compared with angiography-guided grafts (log rank, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11651491/

Clinical value of fractional flow reserve in coronary heart ... This study investigated the clinical value of coronary arteriography (CAG) combined with fractional flow reserve (FFR) in the treatment of coronary heart ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2019.10.060

Utilization and Outcomes of Measuring Fractional Flow ... In patients with SIHD and angiographically intermediate stenoses, use of FFR has slowly risen, and was associated with significantly lower 1-year mortality.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37520135/

Fractional Flow Reserve to Assess Coronary Artery ... Results: At a mean follow-up of 33.7 months, we observed no significant differences in terms of major adverse cardiovascular and cerebrovascular ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1443950621000743

Safety and Long-Term Clinical Outcomes of Fractional ... The FFR was ≤0.80 in 166 and >0.80 in 108 patients. Stable coronary disease was present in 95%. Revascularisation was undertaken in 86.7% of the FFR≤0.80 group ...

10. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.024433

Fractional Flow Reserve and Cardiac Events in Coronary ... Recent studies have reported an increased risk of adverse cardiac events in deferred coronary stenoses with borderline FFR values between 0.75 and 0.85 when ...