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Completed

NCT Number: NCT04631809

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary angiography +/- percutaneous coronary intervention

Procedure

Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography

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

Procedure

Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography

Primary outcomes

  1. Total volume of contrast administered

    Time frame: Immediately post-procedurally

Secondary outcomes

  1. Number of catheters used

    Time frame: Immediately post-procedurally

  2. Total Fluoroscopy time

    Time frame: Immediately post-procedurally

  3. Total Radiation Dose (Effective Dose)

    Time frame: Immediately post-procedurally

  4. Total Procedure time (coronary angiography and possible angioplasty)

    Time frame: Immediately post-procedurally

  5. Rate of complications related to coronary angiography (aortic dissection, coronary artery dissection, stroke, bleeding, puncture site complication)

    Time frame: 1-6 hours

  6. Overall diagnostic accuracy of CTCA for estimation of graft patency will be measured, using sensitivity, specificity, positive predictive value and negative predictive value.

    Time frame: Immediately post-procedurally

  7. 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)

    Time frame: 3-5 days

  8. Patient survival after procedure and occurrence of major adverse cardiovascular events (MACEs). (Death, hospitalization for cardiovascular reason, re-infarction, need for revascularization, stroke).

    Time frame: 30 days

  9. 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.

    Time frame: 3-5 days

  10. Total volume of contrast agent administered during coronary angiography

    Time frame: Immediately post-procedurally

  11. Total Radiation Dose (Effective Dose) during coronary angiography

    Time frame: Immediately post-procedurally

  12. Number of catheters used during coronary angiography

    Time frame: Immediately post-procedurally

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Acronym: GREECE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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