Ischaemic Heart DiseaseBYPASS-CTCANCT07022626
Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients
A study testing CTCA in people with Ischaemic Heart Disease and Contrast-induced Nephropathy, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
Trial summary
A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Heart Disease, Contrast-induced Nephropathy
- What is being tested?
- CTCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Nov 2018to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients undergoing coronary angiography +/-Percutaneous coronary Intervention
- Previous Coronary Artery Bypass Grafting (CABG)
- Aged ≥18
- Patients able and willing to give their written informed consent.
Who cannot join
- Subjects presenting with ST elevation myocardial infarction, cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.
- Subjects with eGFR <20ml/min or on renal replacement therapy.
- Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- Clinical instability including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease or asthma, complete heart block, second-degree atrioventricular block
- Known contrast dye allergy.
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- Pregnancy or unknown pregnancy status.
- 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).
- Inability or refusal to provide informed consent.
- Any inclusion criteria not met
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal London Hospital
London, E1 1FR
St Bartholomew's Hospital
London
About this study
Official title: A Randomised Controlled Trial Assessing the Value of Computed Tomography Cardiac Angiography in Improving Patient Satisfaction and Reducing Contrast Load, Procedural Duration and Complications in Patients Who Had Previous Bypass Surgery Undergoing Coronary Angiography
A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography coronary angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.
Read the detailed description
The BYPASS-CTCA trial is a single-centre, randomised controlled trial, which plans to recruit 688 patients who have had previous bypass grafts and require invasive coronary angiography over a period of 30 months.
Patients will be randomised to receive either computed tomography coronary angiography (CTCA) prior to their invasive coronary angiogram, or invasive coronary angiography alone.
The primary endpoints will be the incidence of contrast induced nephropathy, the duration of the invasive coronary angiographic procedure and patient satisfaction. A number of secondary endpoints will also be looked at.
Findings from BYPASS-CTCA will potentially demonstrate that a CTCA prior to invasive coronary angiography in this cohort of patients reduces the incidence of contrast-induced kidney injury, the length of procedure and improves patients satisfaction. The results of this trial may influence future clinical practice guidelines in coronary artery bypass graft patients undergoing invasive coronary procedures.
- Being tested
- CTCA
- Keywords
- Coronary Artery Bypass Grafts, Computed Tomography Coronary Angiography, Invasive Coronary Angiogram
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTCAProcedure or surgery
Also called Computed Tomography Coronary Angiogram
Computed Tomography Coronary Angiography (CTCA) performed prior to invasive coronary angiography (ICA)
| Study group | Role | What they receive |
|---|---|---|
| CTCA + ICA | Active comparator | Computed Tomography Cardiac Angiography (CTCA) performed prior to invasive coronary angiography (ICA). Receives: Procedure: CTCA |
| ICA only | No intervention | Invasive coronary angiography (ICA) performed only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural duration
To measure the length of coronary angiographic procedure
Measured: timer started after the insertion of the arterial catheter and stopped when the catheters are removed
Incidence of Contrast Induced Nephropathy
Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measured: 48-72 hours
Patient Satisfaction
Patient satisfaction measured by validated questionnaire
Measured: 4-6 hours post angiogram +/- percutaneous coronary intervention
Secondary outcomes (8)
Contrast Amount
Contrast amount (mls) administered during invasive coronary angiography
Measured: During procedure
Radiation Exposure
Radiation exposure (mSv) during invasive coronary angiography
Measured: During procedure
Angiography Related Complications
Angiography related complications (such as coronary or aortic dissection, stroke, bleeding, vascular access complication)
Measured: During procedure
Radial Access Rate
Radial access rates during invasive coronary angiography
Measured: During procedure
Catheters Used
Number of catheters used during invasive coronary angiography
Measured: During procedure
Computed Tomography Cardiac Angiography Accuracy
Accuracy of the computed tomography cardiac angiography scan for detecting graft patency
Measured: Computed Tomography Cardiac Angiography (CTCA)
Number of grafts not identified
Number of grafts not identified during invasive coronary angiography
Measured: During procedure
Cost effectiveness of computed tomography cardiac angiography
Cost effectiveness of the intervention (per quality-adjusted life years) measured over 12 months of follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start14 Nov 2018
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Jones, MRCP, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022626
- Sponsor's protocol ID
- Reda 012466
- Acronym
- BYPASS-CTCA
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial protocol will be published
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Assessing the Value of Computed Tomography Cardiac Angiography in Improving Patient Satisfaction and Reducing Contrast Load, Procedural Duration and Complications in Patients Who Had Previous Bypass Surgery Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT07022626
- Acronym / sponsor ID
- BYPASS-CTCA / Reda 012466
- Keywords
- Coronary Artery Bypass Grafts, Computed Tomography Coronary Angiography, Invasive Coronary Angiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 15 Jun 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.
A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography coronary angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.
Detailed description
The BYPASS-CTCA trial is a single-centre, randomised controlled trial, which plans to recruit 688 patients who have had previous bypass grafts and require invasive coronary angiography over a period of 30 months.
Patients will be randomised to receive either computed tomography coronary angiography (CTCA) prior to their invasive coronary angiogram, or invasive coronary angiography alone.
The primary endpoints will be the incidence of contrast induced nephropathy, the duration of the invasive coronary angiographic procedure and patient satisfaction. A number of secondary endpoints will also be looked at.
Findings from BYPASS-CTCA will potentially demonstrate that a CTCA prior to invasive coronary angiography in this cohort of patients reduces the incidence of contrast-induced kidney injury, the length of procedure and improves patients satisfaction. The results of this trial may influence future clinical practice guidelines in coronary artery bypass graft patients undergoing invasive coronary procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTCA + ICA | Active comparator | Procedure: CTCAComputed Tomography Cardiac Angiography (CTCA) performed prior to invasive coronary angiography (ICA). |
| ICA only | No intervention | –Invasive coronary angiography (ICA) performed only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing coronary angiography +/-Percutaneous coronary Intervention
- Previous Coronary Artery Bypass Grafting (CABG)
- Aged ≥18
- Patients able and willing to give their written informed consent.
Key exclusion criteria (10 listed)
- Subjects presenting with ST elevation myocardial infarction, cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.
- Subjects with eGFR <20ml/min or on renal replacement therapy.
- Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- Clinical instability including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease or asthma, complete heart block, second-degree atrioventricular block
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 Coronary AngiogramComputed Tomography Coronary Angiography (CTCA) performed prior to invasive coronary angiography (ICA) | Procedure or surgery | CTCA + ICA |
Primary outcome
Procedural duration
Time frame: timer started after the insertion of the arterial catheter and stopped when the catheters are removed
To measure the length of coronary angiographic procedure
Incidence of Contrast Induced Nephropathy
Time frame: 48-72 hours
Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Patient Satisfaction
Time frame: 4-6 hours post angiogram +/- percutaneous coronary intervention
Patient satisfaction measured by validated questionnaire
8 secondary outcomes
Contrast Amount
Time frame: During procedure
Radiation Exposure
Time frame: During procedure
Angiography Related Complications
Time frame: During procedure
Radial Access Rate
Time frame: During procedure
Catheters Used
Time frame: During procedure
Computed Tomography Cardiac Angiography Accuracy
Time frame: Computed Tomography Cardiac Angiography (CTCA)
Number of grafts not identified
Time frame: During procedure
Cost effectiveness of computed tomography cardiac angiography
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. The trial protocol will be published
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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. This study is not recruiting at the moment.
Daniel Jones, MRCP, PhD principal investigator
Queen Mary University of London
2 sites 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 Ischaemic Heart Disease and Contrast-induced Nephropathy, run by Barts & The London NHS Trust at 2 sites 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural duration (time frame: timer started after the insertion of the arterial catheter and stopped when the catheters are removed). The study lists 3 primary outcomes in all. 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 15 Jun 2025.