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

NCT ID: NCT03736018

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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 cardiac 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.

Conditions

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Ischaemic Heart Disease Contrast-induced Nephropathy

Keywords

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Coronary Artery Bypass Grafts Computed Tomography Cardiac Angiography Invasive Coronary Angiogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CTCA + ICA

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

Group Type ACTIVE_COMPARATOR

CTCA

Intervention Type DIAGNOSTIC_TEST

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

ICA only

Invasive coronary angiogram (ICA) performed only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CTCA

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Computed Tomography Cardiac angiography

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing invasive coronary angiogram +/- 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Jones, MRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39584261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38462389 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37772419 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34733947 (View on PubMed)

Other Identifiers

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Reda 012466

Identifier Type: -

Identifier Source: org_study_id