Coronary Artery Bypass Surgery
Conditions
Keywords
coronary angiography, CT-Coronary Angiography, Post-artery bypass graft surgery, Coronary artery disease
Brief summary
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
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.
Interventions
Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography
PROCEDURECT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention
Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total volume of contrast administered | Immediately post-procedurally |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Number of catheters used | Immediately post-procedurally |
| Total Fluoroscopy time | Immediately post-procedurally |
| Total Radiation Dose (Effective Dose) | Immediately post-procedurally |
| 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 |
Countries
Greece
Outcome results
None listed