Coronary Artery Bypass Surgery Clinical Trial
— GREECEOfficial title:
Computer tomoGRaphy guidEd invasivE Coronary Angiography in patiEnts With a Previous Coronary Artery Bypass Graft Surgery Trial
Verified date | January 2023 |
Source | University Hospital of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 225 |
Est. completion date | November 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Patras | Patras | Achaia |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Patras |
Greece,
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Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation
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Tsigkas G, Apostolos A, Synetos A, Latsios G, Toutouzas K, Xenogiannis I, Hamilos M, Sianos G, Ziakas A, Tsiafoutis I, Koutouzis M, Toulgaridis F, Moulias A, Sideris A, Patsilinakos S, Kanakakis I, Zampakis P, Tsioufis K, Kochiadakis G, Alexopoulos D, Davlouros P; GREECE Collaborators; Kalogeropoulou C, Vasilagkos G, Koufou EE, Papanikolaou A, Spanou E, Gerakaris A, Chlorogiannis D, Spiropoulou P, Miliordos I, Benetos G, Pappas C, Argentos S, Skalidis E, Kladou E, Skiadas C, Karagiannidis E, Mylona S, Zacharoulis A, Pappas L, Mantis C, Fagrezos D, Manouvelou S, Sertedaki E. Computed tomoGRaphy guidEd invasivE Coronary angiography in patiEnts with a previous coronary artery bypass graft surgery trial (GREECE trial): Rationale and design of a multicenter, randomized control trial. Hellenic J Cardiol. 2021 Nov-Dec;62(6):470-472. doi: 10.1016/j.hjc.2021.01.001. Epub 2021 Jan 20. No abstract available. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total volume of contrast administered | Immediately post-procedurally | ||
Secondary | Number of catheters used | Immediately post-procedurally | ||
Secondary | Total Fluoroscopy time | Immediately post-procedurally | ||
Secondary | Total Radiation Dose (Effective Dose) | Immediately post-procedurally | ||
Secondary | Total Procedure time (coronary angiography and possible angioplasty) | Immediately post-procedurally | ||
Secondary | Rate of complications related to coronary angiography (aortic dissection, coronary artery dissection, stroke, bleeding, puncture site complication) | 1-6 hours | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Total volume of contrast agent administered during coronary angiography | Immediately post-procedurally | ||
Secondary | Total Radiation Dose (Effective Dose) during coronary angiography | Immediately post-procedurally | ||
Secondary | Number of catheters used during coronary angiography | Immediately post-procedurally |
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