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Completed

NCT Number: NCT07022626

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal London Hospital, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

CTCA

Procedure

Computed Tomography Coronary Angiography (CTCA) performed prior to invasive coronary angiography (ICA)

Other names: Computed Tomography Coronary Angiogram

Primary outcomes

  1. 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

  2. Incidence of Contrast Induced Nephropathy

    Time frame: 48-72 hours

    Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria

  3. Patient Satisfaction

    Time frame: 4-6 hours post angiogram +/- percutaneous coronary intervention

    Patient satisfaction measured by validated questionnaire

Secondary outcomes

  1. Contrast Amount

    Time frame: During procedure

    Contrast amount (mls) administered during invasive coronary angiography

  2. Radiation Exposure

    Time frame: During procedure

    Radiation exposure (mSv) during invasive coronary angiography

  3. Angiography Related Complications

    Time frame: During procedure

    Angiography related complications (such as coronary or aortic dissection, stroke, bleeding, vascular access complication)

  4. Radial Access Rate

    Time frame: During procedure

    Radial access rates during invasive coronary angiography

  5. Catheters Used

    Time frame: During procedure

    Number of catheters used during invasive coronary angiography

  6. Computed Tomography Cardiac Angiography Accuracy

    Time frame: Computed Tomography Cardiac Angiography (CTCA)

    Accuracy of the computed tomography cardiac angiography scan for detecting graft patency

  7. Number of grafts not identified

    Time frame: During procedure

    Number of grafts not identified during invasive coronary angiography

  8. Cost effectiveness of computed tomography cardiac angiography

    Time frame: 12 months

    Cost effectiveness of the intervention (per quality-adjusted life years) measured over 12 months of follow-up

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study 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

Acronym: BYPASS-CTCA

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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