Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients (BYPASS-CTCA)

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 Operation Undergoing Invasive Coronary Angiography

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contrast-induced Nephropathy; Ischaemic Heart Disease
• Intervention / Treatment: Diagnostic test: CTCA

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 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.

• Study Type: Interventional
• Enrollment (Actual): 688
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
10. Any inclusion criteria not met

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CTCA + ICA; Computed Tomography Cardiac Angiography (CTCA) performed prior to invasive coronary angiogram (ICA).	Diagnostic test: CTCA; Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).; Other Names: Computed Tomography Cardiac angiography
No Intervention: ICA only; Invasive coronary angiogram (ICA) performed only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast amount	Contrast amount (mls) administered during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Radiation exposure	Radiation exposure (mSv) during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Angiography related complications	Angiography related complications (coronary or aortic dissection, stroke, bleeding, vascular access complications)	4-6hours
Radial access rate	Radial access rates during invasive coronary angiogram	From time of randomisation to end of invasive coronary angiogram procedure
Catheters used	Number of catheters used during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Computed Tomography Cardiac Angiography accuracy	Accuracy of the Computed Tomography Cardiac Angiography scan for detecting graft patency	From time of randomisation to end of invasive coronary angiogram procedure
Number of grafts not identified	Number of grafts not identified during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Cost effectiveness of computed tomography cardiac angiography	Incremental Cost Effectiveness Ratio (ICER)	12 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: Daniel Jones, MRCP, PhD, Queen Mary University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): August 30, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Grafts; Computed Tomography Cardiac Angiography; Invasive Coronary Angiogram
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: Reda 012466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Trial protocol to be published
• IPD Sharing Time Frame: Late 2018
• IPD Sharing Access Criteria: Freely available via journal
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No