iFR Guided Coronary Artery Bypass Grafting Surgery

Recruiting

• Conditions: Coronary Stenosis; Ischaemic Heart Disease; Coronary Artery Disease
• Interventions: Procedure: Coronary artery bypass grafting surgery (CABG)

• Registration Number: NCT04014140
• Lead Sponsor: Prakash Punjabi

Brief Summary

The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.

To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.

It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.

Detailed Description

Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.

Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.

Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.

Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.

Study Timeline

• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-10
• Study Start: 2022-04-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multi-vessel coronary artery disease (MVCAD)	Coronary artery bypass grafting surgery (CABG)	iFR measurements will be taken pre-operatively during the invasive coronary angiography.

Primary Outcome Measures

Name	Time	Method
Graft patency	12 months	The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

Secondary Outcome Measures

Name	Time	Method
Incident of Death (cardiovascular)	12 months	Patient deceased
Composite of MACE (MI, Death, stroke, repeat revascularisation)	12 months	Assessed by the presentation of clinical symptoms and echocardiography during a follow-up visit at 3 months or anytime within 12 months.
Incidence of Myocardial infarction	12 months	Assessed by the presentation of clinical symptoms, echocardiography during a follow-up visit at 3 months or anytime within 12 months and in addition, evidence of percutaneous or surgical revascularisation within the last 12 months.
Incidence of Stroke	12 months	Assessed by the presentation of clinical symptoms during a follow-up visit at 3 and 12 months or anytime within 12 months.
Left ventricular function at 3 months with an echocardiography	3 months	Cardiac functional assessment at 3 months post-opereatively
Quality of Life Questionnaire	3 and 12 months	Patient's view in their quality of life
Any episode of reintervention	12 months	Patient undergoing repeat reintervention
Incidence of Death (all-cause)	12 months	Patient deceased

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust - Hammersmith Hospital; 🇬🇧 London, Greater London, United Kingdom