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

University Hospital of Patras

Status: Completed

Conditions: Coronary Artery Bypass Surgery

Treatments: Procedure: Coronary angiography +/- percutaneous coronary intervention; Procedure: CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04631809

24798/28-9-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 2 patient groups

invasive Coronary Angiography alone

Active Comparator group

Treatment:

Procedure: Coronary angiography +/- percutaneous coronary intervention

CT-Coronary Angiography + invasive Coronary Angiography

Experimental group

Treatment:

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