ClinicalTrials.gg
RecruitingNCT07165678Updated Jun 5, 2026

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

An interventional study of CTCA in Coronary Heart Disease, sponsored by Queen Mary University of London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Queen Mary University of London · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed description

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.

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • Coronary Artery Bypass Graft
  • Angina
  • Coronary Artery Disease
  • CABG
  • percutaneous coronary intervention
  • coronary angiograms
  • Computerised Tomography Coronary Angiography
  • CTCA
03

In context

Coronary Disease

1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 160 across 778 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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)
  • less than 1 year
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • No intervention
    ICA only

    Invasive coronary angiogram (ICA) performed only.

  • Active comparator
    CTCA with or without ICA

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

    Diagnostic Test: CTCA

Interventions

  • Diagnostic testCTCA

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

    Also known as: Computed Tomography Cardiac angiography

06

What researchers measure

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.

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

Secondary outcomes

  1. Fluoroscopy time during coronary angiography

    Unit of Measure: Minutes

    Time frame: During coronary angiography procedure

  2. Incidence of procedural complications during coronary angiography

    Unit of Measure: Number of participants with event

    Time frame: During coronary angiography procedure

  3. Radiation dose during coronary angiography

    Unit of Measure: Milligray (mGy)

    Time frame: During coronary angiography procedure

  4. Contrast dose administered during coronary angiography

    Unit of Measure: Milliliters (mL)

    Time frame: During coronary angiography procedure

  5. Procedural duration during coronary angiography

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

    Time frame: During coronary angiography procedure

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

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

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

  7. Cost-effectiveness and productivity loss

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

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

  8. Days alive and out of hospital

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

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

  9. Length of hospital stay

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

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

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

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

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

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

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

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

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

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

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

  13. Unplanned revascularisation

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

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

  14. Cardiovascular imaging utilisation

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data sharing available from corresponding author upon reasonable request and with approval from trial steering committee.

Supporting information: Study protocol

Time frame: 2028

Access criteria: Freely available via journal

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jul 2029, 39 months after the start.

Of 178 non-industry interventional studies with no phase under Coronary Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 39 months is above that.

Counting every sponsor, half of 200 studies reached it within 25 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2025
First posted
Sep 10, 2025
StartActual
Apr 16, 2026
Primary completionEst.
Jul 31, 2029
CompletionEst.
Jul 31, 2029
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07165678
Collaborators
National Institute for Health Research, United Kingdom
Responsible party
Sponsor
First posted
Sep 10, 2025
Start date
Apr 16, 2026
Primary completion
Jul 31, 2029 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Jun 5, 2026

Study contacts

Mervyn Andiapen
Contact
mervyn.andiapen@nhs.net
0203 765 8707
Matthew Kelham, MBBS, MD
Contact
m.kelham@nhs.net
Daniel Jones, MRCP, PhD
principal investigator · Queen Mary University of London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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