Back to results

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

Primary Purpose

Ischaemic Heart Disease, Contrast-induced Nephropathy

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

CTCA

About this trial

This is an interventional diagnostic trial for Ischaemic Heart Disease focused on measuring Coronary Artery Bypass Grafts, Computed Tomography Cardiac Angiography, Invasive Coronary Angiogram

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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

Sites / Locations

Barts Health NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CTCA + ICA

ICA only

Arm Description

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

Invasive coronary angiogram (ICA) performed only.

Outcomes

Primary Outcome Measures

Procedural duration

Length of invasive coronary angiogram

Incidence of Contrast Induced Nephropathy

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

Patient satisfaction

Patient satisfaction measured by validated questionnaire

Secondary Outcome Measures

Contrast amount

Contrast amount (mls) administered during invasive coronary angiogram

Radiation exposure

Radiation exposure (mSv) during invasive coronary angiogram

Angiography related complications

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

Radial access rate

Radial access rates during invasive coronary angiogram

Catheters used

Number of catheters used during invasive coronary angiogram

Computed Tomography Cardiac Angiography accuracy

Accuracy of the Computed Tomography Cardiac Angiography scan for detecting graft patency

Number of grafts not identified

Number of grafts not identified during invasive coronary angiogram

Cost effectiveness of computed tomography cardiac angiography

Incremental Cost Effectiveness Ratio (ICER)

Full Information

NCT ID

NCT03736018

First Posted

November 5, 2018

Last Updated

December 13, 2022

Sponsor

Queen Mary University of London

1. Study Identification

Unique Protocol Identification Number

NCT03736018

Brief Title

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

Acronym

BYPASS-CTCA

Official 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 Operation Undergoing Invasive Coronary Angiography

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

August 30, 2022 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischaemic Heart Disease, Contrast-induced Nephropathy

Keywords

Coronary Artery Bypass Grafts, Computed Tomography Cardiac Angiography, Invasive Coronary Angiogram

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

688 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CTCA + ICA

Arm Type

Active Comparator

Arm Description

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

Arm Title

ICA only

Arm Type

No Intervention

Arm Description

Invasive coronary angiogram (ICA) performed only.

Intervention Type

Diagnostic Test

Intervention Name(s)

CTCA

Other Intervention Name(s)

Computed Tomography Cardiac angiography

Intervention Description

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

Primary Outcome Measure Information:

Title

Procedural duration

Description

Length of invasive coronary angiogram

Time Frame

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

Title

Incidence of Contrast Induced Nephropathy

Description

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

Time Frame

48-72hours

Title

Patient satisfaction

Description

Patient satisfaction measured by validated questionnaire

Time Frame

4-6hours

Secondary Outcome Measure Information:

Title

Contrast amount

Description

Contrast amount (mls) administered during invasive coronary angiogram

Time Frame

From time of arterial sheath insertion to removal of arterial catheters

Title

Radiation exposure

Description

Radiation exposure (mSv) during invasive coronary angiogram

Time Frame

From time of arterial sheath insertion to removal of arterial catheters

Title

Angiography related complications

Description

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

Time Frame

4-6hours

Title

Radial access rate

Description

Radial access rates during invasive coronary angiogram

Time Frame

From time of randomisation to end of invasive coronary angiogram procedure

Title

Catheters used

Description

Number of catheters used during invasive coronary angiogram

Time Frame

From time of arterial sheath insertion to removal of arterial catheters

Title

Computed Tomography Cardiac Angiography accuracy

Description

Accuracy of the Computed Tomography Cardiac Angiography scan for detecting graft patency

Time Frame

From time of randomisation to end of invasive coronary angiogram procedure

Title

Number of grafts not identified

Description

Number of grafts not identified during invasive coronary angiogram

Time Frame

From time of arterial sheath insertion to removal of arterial catheters

Title

Cost effectiveness of computed tomography cardiac angiography

Description

Incremental Cost Effectiveness Ratio (ICER)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Jones, MRCP, PhD

Organizational Affiliation

Queen Mary University of London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barts Health NHS Trust

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Trial protocol to be published

IPD Sharing Time Frame

Late 2018

IPD Sharing Access Criteria

Freely available via journal

Citations:

PubMed Identifier

34733947

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs