Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients

Not Applicable

Completed

• Conditions: Ischaemic Heart Disease; Contrast-induced Nephropathy

• Registration Number: NCT07022626
• Lead Sponsor: Barts & The London NHS Trust

Brief 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 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 Timeline

• Study Start: 2018-11-14
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Study First Submitted: 2024-11-04
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 688

Inclusion Criteria

1. Patients undergoing coronary angiography +/-Percutaneous coronary Intervention
2. Previous Coronary Artery Bypass Grafting (CABG)
3. Aged ≥18
4. Patients able and willing to give their written informed consent.

Exclusion Criteria

1. 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.
2. Subjects with eGFR <20ml/min or on renal replacement therapy.
3. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
4. Clinical instability including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
5. Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease or asthma, complete heart block, second-degree atrioventricular block
6. Known contrast dye allergy.
7. Pregnancy or unknown pregnancy status.
8. 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).
9. Inability or refusal to provide informed consent.
10. Any inclusion criteria not met

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Procedural duration	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	48-72 hours	Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Patient Satisfaction	4-6 hours post angiogram +/- percutaneous coronary intervention	Patient satisfaction measured by validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Contrast Amount	During procedure	Contrast amount (mls) administered during invasive coronary angiography
Radiation Exposure	During procedure	Radiation exposure (mSv) during invasive coronary angiography
Angiography Related Complications	During procedure	Angiography related complications (such as coronary or aortic dissection, stroke, bleeding, vascular access complication)
Radial Access Rate	During procedure	Radial access rates during invasive coronary angiography
Catheters Used	During procedure	Number of catheters used during invasive coronary angiography
Computed Tomography Cardiac Angiography Accuracy	Computed Tomography Cardiac Angiography (CTCA)	Accuracy of the computed tomography cardiac angiography scan for detecting graft patency
Number of grafts not identified	During procedure	Number of grafts not identified during invasive coronary angiography
Cost effectiveness of computed tomography cardiac angiography	12 months	Cost effectiveness of the intervention (per quality-adjusted life years) measured over 12 months of follow-up

Trial Locations

Locations (2)

Royal London Hospital; 🇬🇧 London, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom