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

NCT04631809 | Completed

• 1 other identifier: 24798/28-9-2020
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Surgery

Keywords

coronary angiography; CT-Coronary Angiography; Post-artery bypass graft surgery; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Total volume of contrast administered

  Immediately post-procedurally

Secondary Outcomes (12)

• Number of catheters used

  Immediately post-procedurally

• Total Fluoroscopy time

  Immediately post-procedurally

• Total Radiation Dose (Effective Dose)

  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

Study Arms (2)

invasive Coronary Angiography alone

ACTIVE COMPARATOR

Procedure: Coronary angiography +/- percutaneous coronary intervention

CT-Coronary Angiography + invasive Coronary Angiography

EXPERIMENTAL

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

Interventions

Coronary angiography +/- percutaneous coronary intervention PROCEDURE

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

invasive Coronary Angiography alone

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

CT-Coronary Angiography + invasive Coronary Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior CABG-operation
• Age\>18 years
• Indication for coronary angiography
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

Related Publications (14)

• Yang FB, Guo WL, Sheng M, Sun L, Ding YY, Xu QQ, Xu MG, Lv HT. Diagnostic accuracy of coronary angiography using 64-slice computed tomography in coronary artery disease. Saudi Med J. 2015 Oct;36(10):1156-62. doi: 10.15537/smj.2015.10.12415.

  PMID: 26446324 BACKGROUND

• Gaudio C, Pelliccia F, Evangelista A, Tanzilli G, Paravati V, Pannarale G, Pannitteri G, Barilla F, Greco C, Franzoni F, Speziale G, Pasceri V. 320-row computed tomography coronary angiography vs. conventional coronary angiography in patients with suspected coronary artery disease: a systematic review and meta-analysis. Int J Cardiol. 2013 Sep 30;168(2):1562-4. doi: 10.1016/j.ijcard.2012.12.067. Epub 2013 Jan 22. No abstract available.

  PMID: 23347611 BACKGROUND

• Delewi R, Hoebers LP, Ramunddal T, Henriques JP, Angeras O, Stewart J, Robertsson L, Wahlin M, Petursson P, Piek JJ, Albertsson P, Matejka G, Omerovic E. Clinical and procedural characteristics associated with higher radiation exposure during percutaneous coronary interventions and coronary angiography. Circ Cardiovasc Interv. 2013 Oct 1;6(5):501-6. doi: 10.1161/CIRCINTERVENTIONS.113.000220. Epub 2013 Sep 24.

  PMID: 24065442 BACKGROUND

• Dikkers R, Willems TP, Tio RA, Anthonio RL, Zijlstra F, Oudkerk M. The benefit of 64-MDCT prior to invasive coronary angiography in symptomatic post-CABG patients. Int J Cardiovasc Imaging. 2007 Jun;23(3):369-77. doi: 10.1007/s10554-006-9170-z. Epub 2006 Nov 4.

  PMID: 17086363 BACKGROUND

• Chazen JL, Prince MR, Yip R, Min JK, Weinsaft JW, Henschke CI, Cham MD. Post-CABG coronary CT angiography: radiation dose and graft image quality in retrospective versus prospective ECG gating. Acad Radiol. 2010 Sep;17(9):1122-7. doi: 10.1016/j.acra.2010.04.011. Epub 2010 Jun 12.

  PMID: 20542451 BACKGROUND

• Lee R, Lim J, Kaw G, Wan G, Ng K, Ho KT. Comprehensive noninvasive evaluation of bypass grafts and native coronary arteries in patients after coronary bypass surgery: accuracy of 64-slice multidetector computed tomography compared to invasive coronary angiography. J Cardiovasc Med (Hagerstown). 2010 Feb;11(2):81-90. doi: 10.2459/JCM.0b013e32832f3e2e.

  PMID: 19851118 BACKGROUND

• Jones DA, Castle EV, Beirne AM, Rathod KS, Treibel TA, Guttmann OP, Moon JC, Smith EJ, Bourantas CV, Davies LC, Wragg A, Pugliese F, Mathur A. Computed tomography cardiac angiography for planning invasive angiographic procedures in patients with previous coronary artery bypass grafting. EuroIntervention. 2020 Feb 7;15(15):e1351-e1357. doi: 10.4244/EIJ-D-18-01185.

  PMID: 31235457 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

• Tsigkas G, Makris A, Tsiafoutis I, Koutouzis M, Hamilos M, Katsanos K, Ziakas A, Brilakis ES, Davlouros P, Hahalis G. The L-RECORD Study. JACC Cardiovasc Interv. 2020 Apr 27;13(8):1014-1016. doi: 10.1016/j.jcin.2020.02.013. No abstract available.

  PMID: 32327086 BACKGROUND

• Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.

  PMID: 24139930 BACKGROUND

• Trattner S, Halliburton S, Thompson CM, Xu Y, Chelliah A, Jambawalikar SR, Peng B, Peters MR, Jacobs JE, Ghesani M, Jang JJ, Al-Khalidi H, Einstein AJ. Cardiac-Specific Conversion Factors to Estimate Radiation Effective Dose From Dose-Length Product in Computed Tomography. JACC Cardiovasc Imaging. 2018 Jan;11(1):64-74. doi: 10.1016/j.jcmg.2017.06.006. Epub 2017 Aug 16.

  PMID: 28823748 BACKGROUND

• Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.

  PMID: 17846343 BACKGROUND

• 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.

  PMID: 33482363 BACKGROUND

• Tsigkas G, Toulgaridis F, Apostolos A, Kalogeropoulos A, Karamasis GV, Vasilagkos G, Pappas L, Toutouzas K, Tsioufis K, Korkonikitas P, Tsiafoutis I, Hamilos M, Ziakas A, Kanakakis I, Moulias A, Zampakis P, Davlouros P. CCTA-Guided Invasive Coronary Angiography in Patients With CABG: A Multicenter, Randomized Study. Circ Cardiovasc Interv. 2024 Sep;17(9):e014045. doi: 10.1161/CIRCINTERVENTIONS.124.014045. Epub 2024 Sep 17.

  PMID: 39286899 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Grigorios Tsigkas, MD, PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

• Periklis Davlouros, MD, PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor of Cardiology

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 17, 2020
• Study Start: October 30, 2020
• Primary Completion: October 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)