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

January 17, 2023 updated by: Grigorios Tsigkas, University Hospital of Patras

Computer tomoGRaphy guidEd invasivE 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26504
        • University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of catheters used
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Total Fluoroscopy time
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Total Radiation Dose (Effective Dose)
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Total Procedure time (coronary angiography and possible angioplasty)
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Rate of complications related to coronary angiography (aortic dissection, coronary artery dissection, stroke, bleeding, puncture site complication)
Time Frame: 1-6 hours
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.
Time Frame: Immediately post-procedurally
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)
Time Frame: 3-5 days
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).
Time Frame: 30 days
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.
Time Frame: 3-5 days
3-5 days
Total volume of contrast agent administered during coronary angiography
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Total Radiation Dose (Effective Dose) during coronary angiography
Time Frame: Immediately post-procedurally
Immediately post-procedurally
Number of catheters used during coronary angiography
Time Frame: Immediately post-procedurally
Immediately post-procedurally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Investigators

  • Principal Investigator: Periklis Davlouros, MD, PhD, University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2020

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

November 7, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24798/28-9-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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