CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)
ConditionCoronary Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18
Previous coronary artery bypass grafting (CABG)
An indication for coronary angiography
Angina
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
CTCA
Diagnostic testComputed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: ICA onlyNo intervention 0 interventions
Group B: CTCA with or without ICAActive comparator 1 intervention
Trial outcomes
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 procedure2
Incidence of procedural complications during coronary angiography
Unit of Measure: Number of participants with event
Time frame
During coronary angiography procedure3
Radiation dose during coronary angiography
Unit of Measure: Milligray (mGy)
Time frame
During coronary angiography procedure4
Contrast dose administered during coronary angiography
Unit of Measure: Milliliters (mL)
Time frame
During coronary angiography procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov