Preoperative FFR for Heart Disease

(IMPAG Trial)

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

120 Participants Needed

What You Need to Know Before You Apply

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.

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.

Is Fractional Flow Reserve (FFR) safe for use in humans?

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. It has been used in real-world settings and clinical trials with positive safety outcomes. ^{1 2 3 4 5}

How is the treatment Fractional Flow Reserve (FFR) unique for heart disease?

Fractional Flow Reserve (FFR) is unique because it is an invasive method that measures pressure differences across a coronary artery to determine the severity of blockages and guide treatment decisions, unlike other methods that rely on visual assessments or non-invasive tests. This approach helps in deciding whether procedures like stenting are necessary, potentially improving outcomes and reducing costs. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Fractional Flow Reserve (FFR) for heart disease?

Research shows that Fractional Flow Reserve (FFR) is useful in assessing the severity of blockages in heart arteries and can help guide treatment decisions, especially in complex heart conditions. It has been associated with good outcomes when used to evaluate patients before and after procedures like stent implantation. ^{11 12 13 14 15}

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. United States pubmed.ncbi.nlm.nih.gov

Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Fractional flow reserve predicts major adverse cardiac events after coronary stent implantation. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Fractional flow reserve and complex coronary pathologic conditions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Should we be using fractional flow reserve more routinely to select stable coronary patients for percutaneous coronary intervention? [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical implications of guiding catheter extubation during fractional flow reserve measurements. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Two-Year Outcomes After Deferral of Revascularization Based on Fractional Flow Reserve: The J-CONFIRM Registry. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practice. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Prognostic impact of FFR/contrast FFR discordance. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic Value of Post-PCI Angiography-Derived Fractional Flow Reserve: A Systematic Review and Meta-Analysis of Cohort Studies. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Very long-term clinical follow-up after fractional flow reserve-guided coronary revascularization. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Association Between Adherence to Fractional Flow Reserve Treatment Thresholds and Major Adverse Cardiac Events in Patients With Coronary Artery Disease. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Frequency of abnormal fractional flow reserve measurements among major coronary arteries. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Use of coronary physiology in the catheterization laboratory to guide treatment in patients with coronary artery disease. [2021]

15. Poland pubmed.ncbi.nlm.nih.gov

Comparison between fractional flow reserve and visual assessment for moderate coronary artery stenosis. [2022]