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NCT Number: NCT07165678

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

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

Recruiting

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Key information

Conditions

Coronary Heart Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Bartholomew's Hospital

London, United Kingdom

Location status: Recruiting

Location contact

Krishna Rathod

CONTACT

02037658707

About this study

Patients with prior coronary artery bypass graft (CABG) surgery frequently present with recurrent angina or acute coronary syndromes due to progressive native coronary artery disease or graft failure. Invasive coronary angiography remains the standard diagnostic approach but is technically challenging in this population due to variable graft anatomy, leading to prolonged procedure times, increased radiation exposure, higher contrast volumes, and elevated risk of procedural complications.

Computed Tomography Coronary Angiography (CTCA) offers a non-invasive alternative with high diagnostic accuracy for graft patency and coronary anatomy. Prior observational data (e.g., BYPASS-CTCA study) suggest that CTCA performed prior to invasive angiography may improve procedural efficiency and safety. However, whether CTCA can guide clinical decision-making to avoid unnecessary angiography and improve long-term outcomes remains unproven.

This multi centre, randomised controlled trial will enrol 1,000 patients with prior CABG presenting with angina or myocardial infarction. Participants will be randomised to either a CTCA-guided strategy or standard care involving direct invasive coronary angiography. In the CTCA arm, angiography may be deferred if CTCA findings support medical management. The primary outcome is the composite rate of major adverse cardiovascular events (MACE), including death, myocardial infarction, stroke, and hospitalisation for unstable angina. Secondary outcomes include procedural metrics, patient-reported quality of life, cost-effectiveness, and healthcare resource utilization.

Clinical data will be collected through patient questionnaires, procedural records, and central registry downloads. The study incorporates patient and public involvement throughout its design and implementation. Results will be disseminated via peer-reviewed publications, public-facing reports, and digital platforms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CTCA

Diagnostic Test

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

Other names: Computed Tomography Cardiac angiography

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Fluoroscopy time during coronary angiography

    Time frame: During coronary angiography procedure

    Unit of Measure: Minutes

  2. Incidence of procedural complications during coronary angiography

    Time frame: During coronary angiography procedure

    Unit of Measure: Number of participants with event

  3. Radiation dose during coronary angiography

    Time frame: During coronary angiography procedure

    Unit of Measure: Milligray (mGy)

  4. Contrast dose administered during coronary angiography

    Time frame: During coronary angiography procedure

    Unit of Measure: Milliliters (mL)

  5. Procedural duration during coronary angiography

    Time frame: During coronary angiography procedure

    Unit of Measure: Minutes Unit of Measure: Milliliters (mL)

  6. Health-related quality of life (EQ-5D-5L)

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

    Assessed using the EQ-5D-5L questionnaire at baseline and every 6 months during follow-up.

  7. Cost-effectiveness and productivity loss

    Time frame: Baseline and every 6 months during follow-up

    Evaluated using patient questionnaires capturing healthcare resource use and productivity loss at baseline and every 6 months.

  8. Days alive and out of hospital

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Total number of days the participant is alive and not admitted to hospital during the follow-up period.

    Unit of Measure: Days

  9. Length of hospital stay

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Days

  10. Major Adverse Cardiovascular Events (MACE) - Individual components

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Number of events

  11. Composite two-point MACE (death and MI)

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Includes death and myocardial infarction as a simplified composite cardiovascular endpoint.

  12. Major Adverse Cardiovascular Events (MACE) - Cumulative incidence

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Total number of MACE events per participant during the follow-up period. Unit of Measure: Number of events

  13. Unplanned revascularisation

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Number of unplanned coronary revascularisation procedures performed during follow-up.

    Unit of Measure: Number of procedures

  14. Cardiovascular imaging utilisation

    Time frame: From randomisation until end of follow-up (up to 2.5 years)

    Number and type of cardiovascular imaging procedures performed during follow-up.

    Unit of Measure: Number of procedures

Study contacts

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

Matthew Kelham, MBBS, MD

CONTACT

[email protected]

Mervyn Andiapen

CONTACT

[email protected]

0203 765 8707

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

A Multi-Centre, Randomised Trial Assessing the Value of Computed Tomography Coronary Angiography Prior to Invasive Coronary Angiography in Patients With Previous Coronary Artery Bypass Grafts in Reducing Cardiac Events

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 10, 2025
Registry last updated
Jun 5, 2026

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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