iFR Guided Coronary Artery Bypass Grafting Surgery

NCT04014140 | Recruiting DMC

• 1 other identifier: 17HH3875
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischaemic Heart Disease; Coronary Artery Disease; Coronary Stenosis

Keywords

Instantaneous wave-free ratio (iFR); Coronary Artery Bypass Grafting (CABG)

Outcome Measures

Primary Outcomes (1)

• Graft patency

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

  12 months

Secondary Outcomes (8)

• Quality of Life Questionnaire

  3 and 12 months

• Composite of MACE (MI, Death, stroke, repeat revascularisation)

  12 months

• Any episode of reintervention

  12 months

• Incidence of Myocardial infarction

  12 months

• Incidence of Stroke

  12 months

Study Arms (1)

Patients with multi-vessel coronary artery disease (MVCAD)

iFR measurements will be taken pre-operatively during the invasive coronary angiography.

Procedure: Coronary artery bypass grafting surgery (CABG)

Interventions

Coronary artery bypass grafting surgery (CABG) PROCEDURE

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

Patients with multi-vessel coronary artery disease (MVCAD)

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prakash Punjabi: lead

Study Sites (1)

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, Greater London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

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

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Panagiotis G Kyriazis, BSc, MRes

CONTACT

020 3313 2026; Panagiotis.Kyriazis@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Cardiothoracic Surgeon

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 10, 2019
• Study Start: April 25, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 36 months
• Access Criteria: According to study protocol

Locations

GB (1)