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

Contrast-induced Nephropathy Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736018
• Other study ID #: Reda 012466
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 688
• Est. completion date: September 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CTCA
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural duration	Length of invasive coronary angiogram	Interval between administration of local anaesthesia for obtaining vascular access and removal of the last catheter
Primary	Incidence of Contrast Induced Nephropathy	Defined by Kidney Disease: Improving Global outcomes (KDIGO) criteria	48-72hours
Primary	Patient satisfaction	Patient satisfaction measured by validated questionnaire	4-6hours
Secondary	Contrast amount	Contrast amount (mls) administered during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Secondary	Radiation exposure	Radiation exposure (mSv) during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Secondary	Angiography related complications	Angiography related complications (coronary or aortic dissection, stroke, bleeding, vascular access complications)	4-6hours
Secondary	Radial access rate	Radial access rates during invasive coronary angiogram	From time of randomisation to end of invasive coronary angiogram procedure
Secondary	Catheters used	Number of catheters used during invasive coronary angiogram	From time of arterial sheath insertion to removal of arterial catheters
Secondary	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
Secondary	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
Secondary	Cost effectiveness of computed tomography cardiac angiography	Incremental Cost Effectiveness Ratio (ICER)	12 months