Coronary Artery Bypass SurgeryGREECENCT04631809
Computed Tomography Coronary Angiography in Patients With a Previous Coronary Artery Bypass Graft Surgery Trial
A study testing Coronary angiography +/- percutaneous coronary intervention and CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention in people with Coronary Artery Bypass Surgery, run by University Hospital of Patras at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- Coronary angiography +/- percutaneous coronary intervention and CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteGreece
- Study dates
- 30 Oct 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior CABG-operation
- Age>18 years
- Indication for coronary angiography
- Informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- Coronary angiography +/- percutaneous coronary intervention, CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention
- Keywords
- coronary angiography, CT-Coronary Angiography, Post-artery bypass graft surgery, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography +/- percutaneous coronary interventionProcedure or surgery
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 interventionProcedure or surgery
Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography
| Study group | Role | What they receive |
|---|---|---|
| invasive Coronary Angiography alone | Active comparator | Not described Receives: Procedure: Coronary angiography +/- percutaneous coronary intervention |
| CT-Coronary Angiography + invasive Coronary Angiography | Experimental | Not described Receives: Procedure: CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of contrast administered
Measured: Immediately post-procedurally
Secondary outcomes (12)
Number of catheters used
Measured: Immediately post-procedurally
Total Fluoroscopy time
Measured: Immediately post-procedurally
Total Radiation Dose (Effective Dose)
Measured: Immediately post-procedurally
Total Procedure time (coronary angiography and possible angioplasty)
Measured: Immediately post-procedurally
Rate of complications related to coronary angiography (aortic dissection, coronary artery dissection, stroke, bleeding, puncture site complication)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 3-5 days
Total volume of contrast agent administered during coronary angiography
Measured: Immediately post-procedurally
Total Radiation Dose (Effective Dose) during coronary angiography
Measured: Immediately post-procedurally
Number of catheters used during coronary angiography
Measured: Immediately post-procedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start30 Oct 2020
- Primary completion30 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grigorios Tsigkas, University Hospital of Patras
- Investigators
- Grigorios Tsigkas, MD, PhD, Principal investigator, University Hospital of PatrasPeriklis Davlouros, MD, PhD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631809
- Sponsor's protocol ID
- 24798/28-9-2020
- Acronym
- GREECE
- Status last verified
- Jan 2023
- First submitted
- 7 Nov 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 26446324Gaudio 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.
PubMed 23347611Delewi 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.
PubMed 24065442Dikkers 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.
PubMed 17086363Chazen 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.
PubMed 20542451Lee 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.
PubMed 19851118Jones 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.
PubMed 31235457Neumann 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.
PubMed 30165437Tsigkas 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.
PubMed 32327086Michael 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.
PubMed 24139930Trattner 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.
PubMed 28823748Einstein 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.
PubMed 17846343Tsigkas 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.
PubMed 33482363Tsigkas 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.
PubMed 39286899
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer tomoGRaphy guidEd invasivE Coronary Angiography in patiEnts With a Previous Coronary Artery Bypass Graft Surgery Trial
- ClinicalTrials.gov ID
- NCT04631809
- Acronym / sponsor ID
- GREECE / 24798/28-9-2020
- Conditions
- Coronary Artery Bypass Surgery
- Keywords
- coronary angiography, CT-Coronary Angiography, Post-artery bypass graft surgery, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior CABG-operation
- Age>18 years
- Indication for coronary angiography
- Informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiography +/- percutaneous coronary interventionComparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography | Procedure or surgery | invasive Coronary Angiography alone |
| CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary interventionComparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography | Procedure or surgery | CT-Coronary Angiography + invasive Coronary Angiography |
Primary outcome
Total volume of contrast administered
Time frame: Immediately post-procedurally
12 secondary outcomes
Number of catheters used
Time frame: Immediately post-procedurally
Total Fluoroscopy time
Time frame: Immediately post-procedurally
Total Radiation Dose (Effective Dose)
Time frame: Immediately post-procedurally
Total Procedure time (coronary angiography and possible angioplasty)
Time frame: 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
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
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
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
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
Total volume of contrast agent administered during coronary angiography
Time frame: Immediately post-procedurally
Total Radiation Dose (Effective Dose) during coronary angiography
Time frame: Immediately post-procedurally
Number of catheters used during coronary angiography
Time frame: Immediately post-procedurally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 26446324Yang 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.
- Background: PubMed 23347611Gaudio 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.
- Background: PubMed 24065442Delewi 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.
- Background: PubMed 17086363Dikkers 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.
- Background: PubMed 20542451Chazen 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.
- Background: PubMed 19851118Lee 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.
- Background: PubMed 31235457Jones 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.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 32327086Tsigkas 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.
- Background: PubMed 24139930Michael 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.
- Background: PubMed 28823748Trattner 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.
- Background: PubMed 17846343Einstein 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grigorios Tsigkas, MD, PhD principal investigator
University Hospital of Patras
Periklis Davlouros, MD, PhD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary angiography +/- percutaneous coronary intervention and CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention in people with Coronary Artery Bypass Surgery, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of contrast administered (time frame: Immediately post-procedurally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631809, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.