Computed Tomography Coronary Angiography in Patients With a Previous Coronary Artery Bypass Graft Surgery Trial

Study Overview
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Brief Summary
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This randomized, multi-center, prospective study seeks to compare the conventional invasive Coronary Angiography with the recently described method of performing CT-Coronary Angiography prior to the invasive Coronary Angiography, in post - CABG patients subjected to coronary angiography or percutaneous coronary intervention.

Detailed Description
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Conventional invasive coronary angiography is currently used to depict coronary arteries, however in recent years, the use of CT-coronary angiography has emerged in the literature for being a non-invasive and well tolerated examination, with imaging findings often equivalent to standard coronary angiography, especially for imaging grafts in patients undergone coronary artery bypass graft surgery (CABG). These patients present with complex anatomy of the coronary arteries making invasive coronary angiography a demanding and time-consuming examination in which the patient is exposed to large doses of radiation and volume of contrast. Multislice computed tomography shows high diagnostic accuracy in the detection of obstruction of the grafts while the advancement of technology continuously improves the diagnostic accuracy of the imaging findings. Of course, axial coronary angiography is more sensitive and specialized in the imaging of grafts, compared to the native coronary arteries of the heart. Therefore, the use of CT-coronary angiography before performing the respective invasive procedure is believed that it may reduce the overall duration of the procedure, the radiation received by the patient and the amount of contrast administered. The aim of the present study is to compare the performance of CT-coronary angiography before invasive coronary angiography compared with the performance of invasive coronary angiography alone. Τhe extent to which the information obtained from CT-coronary angiography contributes to the guidance of invasive coronary angiography that will follow will be studied, regarding the total procedure time, the volume of the contrast administered the radiation to which the patient is exposed and the patient's course over a period of 30 days.

Official Title
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Computer tomoGRaphy guidEd invasivE Coronary Angiography in patiEnts With a Previous Coronary Artery Bypass Graft Surgery Trial

Conditions
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Coronary Artery Bypass Surgery

Intervention / Treatment
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* Procedure: Coronary angiography +/- percutaneous coronary intervention
* Procedure: CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior CABG-operation Age>18 years Indication for coronary angiography Informed consent Exclusion Criteria: STEMI NSTEMI very high risk or high risk (GRACE score >140, dynamic new ST/T ECG changes) Hemodynamic instability High probability of patient's non-compliance with the study's procedures. Severe kidney disease with GFR<30 mL/min/1.73m2 Known allergic reaction to contrast Uncontrolled Arrhythmias (mostly afib) with heart rate over 80 bpm or frequent ectopic beats which could affect the ECG-gated cCTA protocol. BMI>40

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: invasive Coronary Angiography alone<br> | Procedure: Coronary angiography +/- percutaneous coronary intervention<br>* Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography<br>|
| Experimental: CT-Coronary Angiography + invasive Coronary Angiography<br> | Procedure: CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention<br>* Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of contrast administered |  | Immediately post-procedurally | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheters used |  | Immediately post-procedurally | 
| Total Fluoroscopy time |  | Immediately post-procedurally | 
| Total Radiation Dose (Effective Dose) |  | Immediately post-procedurally | 
| Total Procedure time (coronary angiography and possible angioplasty) |  | Immediately post-procedurally | 
| Rate of complications related to coronary angiography (aortic dissection, coronary artery dissection, stroke, bleeding, puncture site complication) |  | 1-6 hours | 
| Overall diagnostic accuracy of CTCA for estimation of graft patency will be measured, using sensitivity, specificity, positive predictive value and negative predictive value. |  | Immediately post-procedurally | 
| Rate of patient survival after procedure and occurrence of major adverse cardiovascular events (MACEs). (Death, hospitalization for cardiovascular reason, re-infarction, need for revascularization, stroke) |  | 3-5 days | 
| Patient survival after procedure and occurrence of major adverse cardiovascular events (MACEs). (Death, hospitalization for cardiovascular reason, re-infarction, need for revascularization, stroke). |  | 30 days | 
| Rate of contrast induced nephropathy defined as increase of serum Cr of 25% or more, or an absolute increase of 0.5 mg/dl or more from baseline value, at 48-72 h following the exposure to contrast medium. |  | 3-5 days | 
| Total volume of contrast agent administered during coronary angiography |  | Immediately post-procedurally | 
| Total Radiation Dose (Effective Dose) during coronary angiography |  | Immediately post-procedurally | 
| Number of catheters used during coronary angiography |  | Immediately post-procedurally | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angiography, CT-Coronary Angiography, Post-artery bypass graft surgery, Coronary artery disease