iFR Guided Coronary Artery Bypass Grafting Surgery

Coronary Artery Disease Clinical Trial

— iCABG  

Official title:

Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04014140
• Other study ID #: 17HH3875
• Status: Recruiting
• Start date: April 25, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP
• Phone: 020 3313 2026
• Email: P.Punjabi[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

INCLUSION CRITERIA

1. Age of 25 to 80 years of age

2. Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery

3. Undergoing isolated first-time elective CABG surgery

4. Available pre-operative angiography data with iFR measurements done during the pre-operative angiography

EXCLUSION CRITERIA

1. Emergency CABG surgery

2. Ejection Fraction= 40%

3. Severe valvular heart disease

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis
• Heart Diseases
• Ischaemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary artery bypass grafting surgery (CABG)
Patients with MVCAD will undergo CABG as per standard of care.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust - Hammersmith Hospital	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Prakash Punjabi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency	The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months.	12 months
Secondary	Quality of Life Questionnaire	Patient's view in their quality of life	3 and 12 months
Secondary	Composite of MACE (MI, Death, stroke, repeat revascularisation)	Assessed by the presentation of clinical symptoms and echocardiography during a follow-up visit at 3 months or anytime within 12 months.	12 months
Secondary	Any episode of reintervention	Patient undergoing repeat reintervention	12 months
Secondary	Incidence of Myocardial infarction	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.	12 months
Secondary	Incidence of Stroke	Assessed by the presentation of clinical symptoms during a follow-up visit at 3 and 12 months or anytime within 12 months.	12 months
Secondary	Left ventricular function at 3 months with an echocardiography	Cardiac functional assessment at 3 months post-opereatively	3 months
Secondary	Incidence of Death (all-cause)	Patient deceased	12 months
Secondary	Incident of Death (cardiovascular)	Patient deceased	12 months