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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736018
Recruitment Status : Active, not recruiting
First Posted : November 8, 2018
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischaemic Heart Disease Contrast-induced Nephropathy Diagnostic Test: CTCA Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : August 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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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 Name: Computed Tomography Cardiac angiography
No Intervention: ICA only
Invasive coronary angiogram (ICA) performed only.


Outcome Measures
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Primary Outcome Measures :
  1. Procedural duration [ Time Frame: Interval between administration of local anaesthesia for obtaining vascular access and removal of the last catheter ]
    Length of invasive coronary angiogram

  2. Incidence of Contrast Induced Nephropathy [ Time Frame: 48-72hours ]
    Defined by Kidney Disease: Improving Global outcomes (KDIGO) criteria

  3. Patient satisfaction [ Time Frame: 4-6hours ]
    Patient satisfaction measured by validated questionnaire


Secondary Outcome Measures :
  1. Contrast amount [ Time Frame: From time of arterial sheath insertion to removal of arterial catheters ]
    Contrast amount (mls) administered during invasive coronary angiogram

  2. Radiation exposure [ Time Frame: From time of arterial sheath insertion to removal of arterial catheters ]
    Radiation exposure (mSv) during invasive coronary angiogram

  3. Angiography related complications [ Time Frame: 4-6hours ]
    Angiography related complications (coronary or aortic dissection, stroke, bleeding, vascular access complications)

  4. Radial access rate [ Time Frame: From time of randomisation to end of invasive coronary angiogram procedure ]
    Radial access rates during invasive coronary angiogram

  5. Catheters used [ Time Frame: From time of arterial sheath insertion to removal of arterial catheters ]
    Number of catheters used during invasive coronary angiogram

  6. Computed Tomography Cardiac Angiography accuracy [ Time Frame: From time of randomisation to end of invasive coronary angiogram procedure ]
    Accuracy of the Computed Tomography Cardiac Angiography scan for detecting graft patency

  7. Number of grafts not identified [ Time Frame: From time of arterial sheath insertion to removal of arterial catheters ]
    Number of grafts not identified during invasive coronary angiogram

  8. Cost effectiveness of computed tomography cardiac angiography [ Time Frame: 12 months ]
    Incremental Cost Effectiveness Ratio (ICER)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736018


Locations
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United Kingdom
Barts Health NHS Trust
London, United Kingdom
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Daniel Jones, MRCP, PhD Queen Mary University of London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03736018    
Other Study ID Numbers: Reda 012466
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Trial protocol to be published
Supporting Materials: Study Protocol
Time Frame: Late 2018
Access Criteria: Freely available via journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Queen Mary University of London:
Coronary Artery Bypass Grafts
Computed Tomography Cardiac Angiography
Invasive Coronary Angiogram
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases