CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)

NCT07165678 | Not Yet Recruiting DMC

• 3 other identifiers: 341412NIHR207209PR2300245
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate whether a coronary computed tomography angiography (CTCA)-guided strategy can reduce the risk of death, heart attack, stroke, and hospital admissions in patients experiencing angina or myocardial infarction following coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are:

• Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography?
• Is CTCA a cost-effective and safer alternative that improves patient quality of life? Researchers will compare outcomes between patients receiving CTCA prior to angiography and those undergoing standard angiography alone to determine if CTCA improves clinical outcomes and procedural safety. Participants will:
• Be randomly assigned to either CTCA-guided care or standard angiography
• Undergo coronary imaging and follow-up assessments
• Complete questionnaires on quality of life and healthcare resource use

Conditions

Coronary Heart Disease

Keywords

Coronary Artery Bypass Graft; Angina; Coronary Artery Disease; CABG; percutaneous coronary intervention; coronary angiograms; Computerised Tomography Coronary Angiography; CTCA

Outcome Measures

Primary Outcomes (1)

• Composite major adverse cardiovascular events (MACE): all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation

  Clinical events will be assessed from randomisation until the final patient completes 6 months of follow-up. The composite endpoint includes all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation. Based on a 2-year recruitment period, individual follow-up will range from 0.5 to 2.5 years, with an estimated median follow-up of 18 months.

  Up to 2.5 years post-randomisation (median follow-up: 18 months)

Secondary Outcomes (14)

• Fluoroscopy time during coronary angiography

  During coronary angiography procedure

• Incidence of procedural complications during coronary angiography

  During coronary angiography procedure

• Radiation dose during coronary angiography

  During coronary angiography procedure

• Contrast dose administered during coronary angiography

  During coronary angiography procedure

• Procedural duration during coronary angiography

  During coronary angiography procedure

Study Arms (2)

ICA only

NO INTERVENTION

Invasive coronary angiogram (ICA) performed only.

CTCA with or without ICA

ACTIVE COMPARATOR

Computed Tomography Cardiac Angiography (CTCA) with or without invasive coronary angiogram (ICA)

Diagnostic Test: CTCA

Interventions

CTCA DIAGNOSTIC_TEST

Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).

Also known as: Computed Tomography Cardiac angiography

CTCA with or without ICA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18
• Previous coronary artery bypass grafting (CABG)
• An indication for coronary angiography
• Angina
• Ischaemia on perfusion imaging
• Acute coronary syndrome
• Patients are able and willing to give their written informed consent

You may not qualify if:

• Subjects presenting with ST segment myocardial infarction within window for primary PCI
• Patients considered unsuitable to participate by the research team (e.g. due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures)
• Life expectancy less than 1 year

Sponsors & Collaborators

• Queen Mary University of London: lead
• National Institute for Health Research, United Kingdom: collaborator

MeSH Terms

Conditions

Coronary Disease; Angina Pectoris; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Daniel Jones, MRCP, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mervyn Andiapen

CONTACT

0203 765 8707; mervyn.andiapen@nhs.net

Matthew Kelham, MBBS, MD

CONTACT

m.kelham@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm A: coronary angiography alone Arm B: CTCA scan with or without angiography

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 10, 2025
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2028
• Access Criteria: Freely available via journal