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

NCT07022626 | Completed DMC

• 1 other identifier: Reda 012466
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischaemic Heart Disease; Contrast-induced Nephropathy

Keywords

Coronary Artery Bypass Grafts; Computed Tomography Coronary Angiography; Invasive Coronary Angiogram

Outcome Measures

Primary Outcomes (3)

• Procedural duration

  To measure the length of coronary angiographic procedure

  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

  48-72 hours

• Patient Satisfaction

  Patient satisfaction measured by validated questionnaire

  4-6 hours post angiogram +/- percutaneous coronary intervention

Secondary Outcomes (8)

• Contrast Amount

  During procedure

• Radiation Exposure

  During procedure

• Angiography Related Complications

  During procedure

• Radial Access Rate

  During procedure

• Catheters Used

  During procedure

Study Arms (2)

CTCA + ICA

ACTIVE COMPARATOR

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

Procedure: CTCA

ICA only

NO INTERVENTION

Invasive coronary angiography (ICA) performed only.

Interventions

CTCA PROCEDURE

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

Also known as: Computed Tomography Coronary Angiogram

CTCA + ICA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (2)

Royal London Hospital

London, E1 1FR, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Daniel Jones, MRCP, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: June 15, 2025
• Study Start: November 14, 2018
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Mid-late 2018
• Access Criteria: Freely available via journal

Locations

GB (2)