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

NCT03736018 | Unknown DMC

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

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 cardiac 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 Cardiac Angiography; Invasive Coronary Angiogram

Outcome Measures

Primary Outcomes (3)

• Procedural duration

  Length of invasive coronary angiogram

  Interval between administration of local anaesthesia for obtaining vascular access and removal of the last catheter

• Incidence of Contrast Induced Nephropathy

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

  48-72hours

• Patient satisfaction

  Patient satisfaction measured by validated questionnaire

  4-6hours

Secondary Outcomes (8)

• Contrast amount

  From time of arterial sheath insertion to removal of arterial catheters

• Radiation exposure

  From time of arterial sheath insertion to removal of arterial catheters

• Angiography related complications

  4-6hours

• Radial access rate

  From time of randomisation to end of invasive coronary angiogram procedure

• Catheters used

  From time of arterial sheath insertion to removal of arterial catheters

Study Arms (2)

CTCA + ICA

ACTIVE COMPARATOR

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

Diagnostic Test: CTCA

ICA only

NO INTERVENTION

Invasive coronary angiogram (ICA) performed only.

Interventions

CTCA DIAGNOSTIC_TEST

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

Also known as: Computed Tomography Cardiac angiography

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 invasive coronary angiogram +/- 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

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

Related Publications (4)

• Kelham M, Beirne AM, Rathod KS, Andiapen M, Wynne L, Learoyd AE, Forooghi N, Ramaseshan R, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA. CTCA Prior to Invasive Coronary Angiography in Patients With Previous Bypass Surgery: Patient-Related Outcomes, Imaging Resource Utilization, and Cardiac Events at 3 Years From the BYPASS-CTCA Trial. Circ Cardiovasc Interv. 2024 Dec;17(12):e014142. doi: 10.1161/CIRCINTERVENTIONS.124.014142. Epub 2024 Nov 25.

  PMID: 39584261 DERIVED

• Kelham M, Beirne AM, Rathod KS, Andiapen M, Wynne L, Ramaseshan R, Learoyd AE, Forooghi N, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA; BYPASS-CTCA Trial Investigators. The effect of CTCA guided selective invasive graft assessment on coronary angiographic parameters and outcomes: Insights from the BYPASS-CTCA trial. J Cardiovasc Comput Tomogr. 2024 May-Jun;18(3):291-296. doi: 10.1016/j.jcct.2024.03.004. Epub 2024 Mar 11.

  PMID: 38462389 DERIVED

• Jones DA, Beirne AM, Kelham M, Rathod KS, Andiapen M, Wynne L, Godec T, Forooghi N, Ramaseshan R, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A; BYPASS-CTCA Trial Committees and Investigators. Computed Tomography Cardiac Angiography Before Invasive Coronary Angiography in Patients With Previous Bypass Surgery: The BYPASS-CTCA Trial. Circulation. 2023 Oct 31;148(18):1371-1380. doi: 10.1161/CIRCULATIONAHA.123.064465. Epub 2023 Sep 29.

  PMID: 37772419 DERIVED

• Beirne AM, Rathod KS, Castle E, Andiapen M, Richards A, Bellin A, Hammond V, Godec T, Moon JC, Davies C, Bourantas CV, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA. The BYPASS-CTCA Study: the value of Computed Tomography Cardiac Angiography (CTCA) in improving patient-related outcomes in patients with previous bypass operation undergoing invasive coronary angiography: Study Protocol of a Randomised Controlled Trial. Ann Transl Med. 2021 Sep;9(17):1395. doi: 10.21037/atm-21-1455.

  PMID: 34733947 DERIVED

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 5, 2018
• First Posted: November 8, 2018
• Study Start: November 15, 2018
• Primary Completion: August 30, 2022
• Study Completion: September 30, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

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

Locations

GB (1)