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iFR Guided Coronary Artery Bypass Grafting Surgery

Sponsor: Prakash Punjabi

NCT ID: NCT04014140

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Coronary artery bypass grafting surgery (CABG) (procedure)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
Coronary artery bypass grafting surgery (CABG) — procedure: Patients with MVCAD will undergo CABG as per standard of care.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
25 Years to 80 Years
Who
All
Number of participants
100
Started
2022-04-25
Last checked
2023-11

Plain English Summary

What is this study?

  • • Testing a new treatment for ischaemic heart disease
  • • Clinical study - 100 participants
  • • 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

Who can take part?

  • • Ages 25 Years to 80 Years
  • • Diagnosed with ischaemic heart disease

Where?

  • • London - Imperial College Healthcare NHS Trust - Hammersmith Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Ischaemic Heart DiseaseCoronary Artery DiseaseCoronary Stenosis

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓INCLUSION CRITERIA
  • ✓Age of 25 to 80 years of age
  • ✓Willing to participate and able to understand, read and sign the agreement to take part form (ICF) before the usual treatment...
  • ✓Undergoing isolated first-time elective CABG surgery
  • ✓Available pre-operative angiography data with iFR measurements done during the pre-operative angiography
See the full criteria
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

Where Is This Study? (1 UK site)

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCPPrincipal Investigator

How to Get in Touch

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

Sponsor contact

CONTACT

020 3313 2026 P.Punjabi@imperial.ac.uk

Panagiotis G Kyriazis, BSc, MRes

Sponsor contact

CONTACT

020 3313 2026 Panagiotis.Kyriazis@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2023-11