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iFR Guided Coronary Artery Bypass Grafting Surgery

ConditionsIschaemic Heart DiseaseCoronary Artery DiseaseCoronary Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-80
SponsorPrakash Punjabi

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency CABG surgery

Ejection Fraction≤ 40%

Severe valvular heart disease

Trial population

Retrospective cohort study - approximately 250 pts Prospective cohort study - minimum 28 pts - maximum 100 pts

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coronary artery bypass grafting surgery (CABG)

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with multi-vessel coronary artery disease (MVCAD)1 intervention

Trial outcomes

Primary outcomes

1

Graft patency

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

Time frame
12 months

Secondary outcomes

1

Quality of Life Questionnaire

Patient's view in their quality of life

Time frame
3 and 12 months
2

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.

Time frame
12 months
3

Any episode of reintervention

Patient undergoing repeat reintervention

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prakash Punjabi

Lead sponsor

Imperial College Healthcare NHS Trust

Sponsor institution

Source ClinicalTrials.gov
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