Coronary Heart DiseaseNCT07165678
CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)
A study testing CTCA in people with Coronary Heart Disease, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- CTCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew Kelham, MBBS, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London
Krishna Rathod, 02037658707
About this study
Official 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
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.
Read more
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.
- Conditions
- Coronary Heart Disease
- Being tested
- CTCA
- Keywords
- Coronary Artery Bypass Graft, Angina, Coronary Artery Disease, CABG, percutaneous coronary intervention, coronary angiograms, Computerised Tomography Coronary Angiography, CTCA
- Medical subject headings
- Coronary Disease, Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTCADiagnostic test
Also called Computed Tomography Cardiac angiography
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: CTCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2.5 years post-randomisation (median follow-up: 18 months)
Secondary outcomes (14)
Fluoroscopy time during coronary angiography
Unit of Measure: Minutes
Measured: During coronary angiography procedure
Incidence of procedural complications during coronary angiography
Unit of Measure: Number of participants with event
Measured: During coronary angiography procedure
Radiation dose during coronary angiography
Unit of Measure: Milligray (mGy)
Measured: During coronary angiography procedure
Contrast dose administered during coronary angiography
Unit of Measure: Milliliters (mL)
Measured: During coronary angiography procedure
Procedural duration during coronary angiography
Unit of Measure: Minutes Unit of Measure: Milliliters (mL)
Measured: During coronary angiography procedure
Health-related quality of life (EQ-5D-5L)
Assessed using the EQ-5D-5L questionnaire at baseline and every 6 months during follow-up.
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Cost-effectiveness and productivity loss
Evaluated using patient questionnaires capturing healthcare resource use and productivity loss at baseline and every 6 months.
Measured: Baseline and every 6 months during follow-up
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
Measured: From randomisation until end of follow-up (up to 2.5 years)
Length of hospital stay
Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Days
Measured: From randomisation until end of follow-up (up to 2.5 years)
Major Adverse Cardiovascular Events (MACE) - Individual components
Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Number of events
Measured: From randomisation until end of follow-up (up to 2.5 years)
Composite two-point MACE (death and MI)
Includes death and myocardial infarction as a simplified composite cardiovascular endpoint.
Measured: From randomisation until end of follow-up (up to 2.5 years)
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
Measured: From randomisation until end of follow-up (up to 2.5 years)
Unplanned revascularisation
Number of unplanned coronary revascularisation procedures performed during follow-up.
Unit of Measure: Number of procedures
Measured: From randomisation until end of follow-up (up to 2.5 years)
Cardiovascular imaging utilisation
Number and type of cardiovascular imaging procedures performed during follow-up.
Unit of Measure: Number of procedures
Measured: From randomisation until end of follow-up (up to 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start16 Apr 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A: coronary angiography alone Arm B: CTCA scan with or without angiography
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Daniel Jones, MRCP, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165678
- Sponsor's protocol ID
- 341412
- Other IDs
- NIHR207209, PR2300245
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing available from corresponding author upon reasonable request and with approval from trial steering committee.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07165678
- Acronym / sponsor ID
- 341412
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Artery Bypass Graft, Angina, Coronary Artery Disease, CABG, percutaneous coronary intervention, coronary angiograms, Computerised Tomography Coronary Angiography, CTCA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A: coronary angiography alone Arm B: CTCA scan with or without angiography
| Arm | Type | Receives |
|---|---|---|
| ICA only | No intervention | –Invasive coronary angiogram (ICA) performed only. |
| CTCA with or without ICA | Active comparator | Diagnostic Test: CTCAComputed Tomography Cardiac Angiography (CTCA) with or without invasive coronary angiogram (ICA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18
- Previous coronary artery bypass grafting (CABG)
- An indication for coronary angiography
- Patients are able and willing to give their written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTCAAlso: Computed Tomography Cardiac angiographyComputed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA). | Diagnostic test | CTCA with or without ICA |
Primary outcome
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.
14 secondary outcomes
Fluoroscopy time during coronary angiography
Time frame: During coronary angiography procedure
Incidence of procedural complications during coronary angiography
Time frame: During coronary angiography procedure
Radiation dose during coronary angiography
Time frame: During coronary angiography procedure
Contrast dose administered during coronary angiography
Time frame: During coronary angiography procedure
Procedural duration during coronary angiography
Time frame: During coronary angiography procedure
Health-related quality of life (EQ-5D-5L)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Cost-effectiveness and productivity loss
Time frame: Baseline and every 6 months during follow-up
Days alive and out of hospital
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Length of hospital stay
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Major Adverse Cardiovascular Events (MACE) - Individual components
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Composite two-point MACE (death and MI)
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Major Adverse Cardiovascular Events (MACE) - Cumulative incidence
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Unplanned revascularisation
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Cardiovascular imaging utilisation
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Data sharing available from corresponding author upon reasonable request and with approval from trial steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Kelham, MBBS, MD contact
Daniel Jones, MRCP, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTCA in people with Coronary Heart Disease, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mervyn Andiapen (0203 765 8707, mervyn.andiapen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.