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NCT Number: NCT04014140

iFR Guided Coronary Artery Bypass Grafting Surgery

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.

Recruiting

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, Greater London, W12 0HS, United Kingdom

Location status: Recruiting

Location contact

Becky Ward

CONTACT

[email protected]

02075949459 ext. +44

Jaspal Kooner, MD, FRCP

SUB_INVESTIGATOR

Panagiotis G Kyriazis, BSc, MRes

SUB_INVESTIGATOR

Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 25 to 80 years of age
  • Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery
  • Undergoing isolated first-time elective CABG surgery
  • Available pre-operative angiography data with iFR measurements done during the pre-operative angiography

Exclusion criteria

  • Emergency CABG surgery
  • Ejection Fraction≤ 40%
  • Severe valvular heart disease

Treatment and study plan

Coronary artery bypass grafting surgery (CABG)

Procedure

Patients with MVCAD will undergo CABG as per standard of care.

Primary outcomes

  1. Graft patency

    Time frame: 12 months

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

Secondary outcomes

  1. Quality of Life Questionnaire

    Time frame: 3 and 12 months

    Patient's view in their quality of life

  2. Composite of MACE (MI, Death, stroke, repeat revascularisation)

    Time frame: 12 months

    Assessed by the presentation of clinical symptoms and echocardiography during a follow-up visit at 3 months or anytime within 12 months.

  3. Any episode of reintervention

    Time frame: 12 months

    Patient undergoing repeat reintervention

  4. Incidence of Myocardial infarction

    Time frame: 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.

  5. Incidence of Stroke

    Time frame: 12 months

    Assessed by the presentation of clinical symptoms during a follow-up visit at 3 and 12 months or anytime within 12 months.

  6. Left ventricular function at 3 months with an echocardiography

    Time frame: 3 months

    Cardiac functional assessment at 3 months post-opereatively

  7. Incidence of Death (all-cause)

    Time frame: 12 months

    Patient deceased

  8. Incident of Death (cardiovascular)

    Time frame: 12 months

    Patient deceased

Study contacts

Contact information is provided by the study sponsor or research team.

Panagiotis G Kyriazis, BSc, MRes

CONTACT

[email protected]

020 3313 2026 ext. +44

Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP

CONTACT

[email protected]

020 3313 2026 ext. +44

Sponsors and collaborators

Lead sponsor

Prakash Punjabi

Other

Registry information

Official study title

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

Acronym: iCABG

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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