Coronary Artery DiseaseNCT04142021
Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by National University of Ireland, Galway, Ireland at 3 sites in 3 countries.
Trial summary
To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- What is being tested?
- Coronary computed tomography angiography
- How many people
- 114 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients with 3-vessel disease with or without left main involvement referred to CABG treatment.
Who may be able to join
- Patients referred to CABG treatment (as assessed by 'conventional heart team') having at the time of the conventional heart team evaluation at least 1 de novo stenotic lesion (with a visually assessed DS with ≥ 50%) in all 3 major epicardial territories [left anterior descending (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, right coronary artery (RCA) and/or side branch] supplying viable myocardium with or without left main involvement
- Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and LCX territories may be included in the trial as a 3VD equivalent. Ostial LAD plus ostial LCX may be included in the trial as a left main equivalent
- Distal vessel size should be at least 1.5 mm in diameter as visually assessed in the diagnostic angiogram (as requested by the surgeons)
- Patients with silent ischemia, chronic coronary syndrome or stabilized acute coronary syndrome with normalized (stable or decreasing) cardiac biomarker values. For patients showing elevated troponin (cTn) (e.g. non-ST elevation myocardial infarction [NSTEMI] patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to CABG to confirm that: a) hs-cTn or troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped 25; b) creatine kinase-muscle/brain (CK-MB) and creatine kinase (CK) levels are within normal range. If hs-cTn or troponin I or T levels are stable or have dropped, or the CK-MB and CK levels are within normal ranges and the ECG is normal, patients may be included in the study
- All anatomical SYNTAX Scores are eligible
- Patients are amenable to coronary CTA (e.g. no claustrophobia, high heart rate not amenable to beta-blockers, poor renal function, etc., up to the discretion of the investigator)
- Patients have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the Ethical Committee of the respective clinical site
- Patients agree to 1-month follow-up visit including coronary CTA
Who cannot join
- Under the age of 18 years
- Unable to give informed consent
- Known pregnancy at the time of enrollment; female of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); female who is breastfeeding at time of enrollment
- Prior PCI or CABG; history of coronary stent implantation
- Evidence of evolving or ongoing ST-elevation MI (STEMI) on ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment (non-STEMI)
- Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment)
Show all 13Show fewer
- Concomitant cardiac valve disease requiring surgical therapy (repair or replacement) and/or aneurysmectomy
- Single or two-vessel disease (at time of the conventional heart team consensus)
- Non-graftable distal bed in >1 vessel as assessed by the surgeon based on ICA
- Persistent atrial fibrillation or significant arrhythmias
- Known allergy to iodinated contrast
- A body mass index (BMI) of 35 or greater
- Currently participating in another clinical trial not yet at its primary endpoint
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Brussels
Brussels
Mark La Meir, MD, PhD
Johan de Mey, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Jena
Jena
Torsten Doenst, MD, PhD
Ulf Teichgräber, MD
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan
Giulio Pompilio, MD, PhD
Daniele Andreini, MD, PhD
About this study
Official title: A Multicenter, Pilot Study to Evaluate Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)
To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Being tested
- Coronary computed tomography angiography
- Keywords
- coronary artery bypass graft, coronary computed tomography angiography, fractional flow reserve derived from computed tomography angiography, invasive coronary angiography, revascularization
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomography angiographyDiagnostic test
Surgery planning done based solely on coronary computed tomography angiography.
| Study group | Role | What they receive |
|---|---|---|
| patients with 3-vessel disease with or without left main | Patients with 3-vessel disease with or without left main involvement referred to CABG treatment based on coronary angiography. Receives: Diagnostic Test: Coronary computed tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility expressed in percentage of CABG planning and execution solely based on coronary CTA in 114 candidates for CABG (i.e. the 'CTA heart team' and the operator being blind for the ICA). [percentage/rate].
Measured: 2 weeks after enrollment
Safety: The rate of graft stenosis [≥ 50% diameter stenosis (DS) - 99% DS] or occlusion (100% DS) either at the ostium, in the shaft or at the level of the sequential anastomosis or at the distal anastomosis of each individual graft based on coronary CTA
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Responsible party
- Principal investigator, Patrick Serruys, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142021
- Sponsor's protocol ID
- FASTTRACK CABG
- Status last verified
- Apr 2022
- First submitted
- 25 Oct 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy. Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.
Publications
Revaiah PC, Tsai TY, Farina J, Ferraz-Costa G, Jongenotter J, Oshima A, Garg S, Puskas JD, Narula J, Gupta H, Agarwal V, Tanaka K, De Mey J, La Meir M, Schneider U, Kirov H, Saima M, Teichgraber U, Pompilio G, Pontone G, Andreini D, Morel MA, Doenst T, Onuma Y, Serruys PW. High-risk plaques in proximal and distal segments relative to graft anastomoses and non-grafted segments. J Cardiovasc Comput Tomogr. 2025 Nov-Dec;19(6):684-693. doi: 10.1016/j.jcct.2025.09.013. Epub 2025 Oct 9.
PubMed 41068029Miyashita K, Onuma Y, Oshima A, Tobe A, Tsai TY, Revaiah PC, Tu S, Reiber JHC, Andreini D, Mushtaq S, Pontone G, Pompilio G, De Mey J, Tanaka K, La Meir M, Kirov H, Doenst T, Teichgraber U, Narula J, Puskas JD, Gupta H, Garg S, Serruys PW. Fractional flow reserve from coronary CT angiography compared with quantitative flow ratio in complex CAD. J Cardiovasc Comput Tomogr. 2025 Nov-Dec;19(6):701-710. doi: 10.1016/j.jcct.2025.09.001. Epub 2025 Sep 22.
PubMed 40983565Masuda S, Revaiah PC, Kageyama S, Tsai TY, Miyashita K, Tobe A, Puskas JD, Teichgraber U, Schneider U, Doenst T, Tanaka K, De Mey J, La Meir M, Mushtaq S, Bartorelli AL, Pompilio G, Garg S, Andreini D, Onuma Y, Serruys PW. Quantitative coronary computed tomography assessment for differentiating between total occlusions and severe stenoses. J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):450-456. doi: 10.1016/j.jcct.2024.04.013. Epub 2024 May 7.
PubMed 38714459Serruys PW, Kageyama S, Pompilio G, Andreini D, Pontone G, Mushtaq S, La Meir M, De Mey J, Tanaka K, Doenst T, Teichgraber U, Schneider U, Puskas JD, Narula J, Gupta H, Agarwal V, Leipsic J, Masuda S, Kotoku N, Tsai TY, Garg S, Morel MA, Onuma Y. Coronary bypass surgery guided by computed tomography in a low-risk population. Eur Heart J. 2024 May 27;45(20):1804-1815. doi: 10.1093/eurheartj/ehae199.
PubMed 38583086Kawashima H, Pompilio G, Andreini D, Bartorelli AL, Mushtaq S, Ferrari E, Maisano F, Buechel RR, Tanaka K, La Meir M, De Mey J, Schneider U, Doenst T, Teichgraber U, Stone GW, Sharif F, de Winter R, Thomsen B, Taylor C, Rogers C, Leipsic J, Wijns W, Onuma Y, Serruys PW. Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study. BMJ Open. 2020 Dec 10;10(12):e038152. doi: 10.1136/bmjopen-2020-038152.
PubMed 33303435
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Pilot Study to Evaluate Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)
- ClinicalTrials.gov ID
- NCT04142021
- Acronym / sponsor ID
- FASTTRACK CABG
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Keywords
- coronary artery bypass graft, coronary computed tomography angiography, fractional flow reserve derived from computed tomography angiography, invasive coronary angiography, revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Oct 2019 (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.
To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with 3-vessel disease with or without left main | – | Diagnostic Test: Coronary computed tomography angiographyPatients with 3-vessel disease with or without left main involvement referred to CABG treatment based on coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 3-vessel disease with or without left main involvement referred to CABG treatment.
Key inclusion criteria (8 listed)
- Patients referred to CABG treatment (as assessed by 'conventional heart team') having at the time of the conventional heart team evaluation at least 1 de novo stenotic lesion (with a visually assessed DS with ≥ 50%) in all 3 major epicardial territories [left anterior descending (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, right coronary artery (RCA) and/or side branch] supplying viable myocardium with or without left main involvement
- Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and LCX territories may be included in the trial as a 3VD equivalent. Ostial LAD plus ostial LCX may be included in the trial as a left main equivalent
- Distal vessel size should be at least 1.5 mm in diameter as visually assessed in the diagnostic angiogram (as requested by the surgeons)
- Patients with silent ischemia, chronic coronary syndrome or stabilized acute coronary syndrome with normalized (stable or decreasing) cardiac biomarker values. For patients showing elevated troponin (cTn) (e.g. non-ST elevation myocardial infarction [NSTEMI] patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to CABG to confirm that: a) hs-cTn or troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped 25; b) creatine kinase-muscle/brain (CK-MB) and creatine kinase (CK) levels are within normal range. If hs-cTn or troponin I or T levels are stable or have dropped, or the CK-MB and CK levels are within normal ranges and the ECG is normal, patients may be included in the study
- All anatomical SYNTAX Scores are eligible
Key exclusion criteria (13 listed)
- Under the age of 18 years
- Unable to give informed consent
- Known pregnancy at the time of enrollment; female of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); female who is breastfeeding at time of enrollment
- Prior PCI or CABG; history of coronary stent implantation
- Evidence of evolving or ongoing ST-elevation MI (STEMI) on ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment (non-STEMI)
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 computed tomography angiographySurgery planning done based solely on coronary computed tomography angiography. | Diagnostic test | patients with 3-vessel disease with or without left main |
Primary outcome
Feasibility expressed in percentage of CABG planning and execution solely based on coronary CTA in 114 candidates for CABG (i.e. the 'CTA heart team' and the operator being blind for the ICA). [percentage/rate].
Time frame: 2 weeks after enrollment
Safety: The rate of graft stenosis [≥ 50% diameter stenosis (DS) - 99% DS] or occlusion (100% DS) either at the ostium, in the shaft or at the level of the sequential anastomosis or at the distal anastomosis of each individual graft based on coronary CTA
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 41068029Revaiah PC, Tsai TY, Farina J, Ferraz-Costa G, Jongenotter J, Oshima A, Garg S, Puskas JD, Narula J, Gupta H, Agarwal V, Tanaka K, De Mey J, La Meir M, Schneider U, Kirov H, Saima M, Teichgraber U, Pompilio G, Pontone G, Andreini D, Morel MA, Doenst T, Onuma Y, Serruys PW. High-risk plaques in proximal and distal segments relative to graft anastomoses and non-grafted segments. J Cardiovasc Comput Tomogr. 2025 Nov-Dec;19(6):684-693. doi: 10.1016/j.jcct.2025.09.013. Epub 2025 Oct 9.
- Derived from this study: PubMed 40983565Miyashita K, Onuma Y, Oshima A, Tobe A, Tsai TY, Revaiah PC, Tu S, Reiber JHC, Andreini D, Mushtaq S, Pontone G, Pompilio G, De Mey J, Tanaka K, La Meir M, Kirov H, Doenst T, Teichgraber U, Narula J, Puskas JD, Gupta H, Garg S, Serruys PW. Fractional flow reserve from coronary CT angiography compared with quantitative flow ratio in complex CAD. J Cardiovasc Comput Tomogr. 2025 Nov-Dec;19(6):701-710. doi: 10.1016/j.jcct.2025.09.001. Epub 2025 Sep 22.
- Derived from this study: PubMed 38714459Masuda S, Revaiah PC, Kageyama S, Tsai TY, Miyashita K, Tobe A, Puskas JD, Teichgraber U, Schneider U, Doenst T, Tanaka K, De Mey J, La Meir M, Mushtaq S, Bartorelli AL, Pompilio G, Garg S, Andreini D, Onuma Y, Serruys PW. Quantitative coronary computed tomography assessment for differentiating between total occlusions and severe stenoses. J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):450-456. doi: 10.1016/j.jcct.2024.04.013. Epub 2024 May 7.
- Derived from this study: PubMed 38583086Serruys PW, Kageyama S, Pompilio G, Andreini D, Pontone G, Mushtaq S, La Meir M, De Mey J, Tanaka K, Doenst T, Teichgraber U, Schneider U, Puskas JD, Narula J, Gupta H, Agarwal V, Leipsic J, Masuda S, Kotoku N, Tsai TY, Garg S, Morel MA, Onuma Y. Coronary bypass surgery guided by computed tomography in a low-risk population. Eur Heart J. 2024 May 27;45(20):1804-1815. doi: 10.1093/eurheartj/ehae199.
- Derived from this study: PubMed 33303435Kawashima H, Pompilio G, Andreini D, Bartorelli AL, Mushtaq S, Ferrari E, Maisano F, Buechel RR, Tanaka K, La Meir M, De Mey J, Schneider U, Doenst T, Teichgraber U, Stone GW, Sharif F, de Winter R, Thomsen B, Taylor C, Rogers C, Leipsic J, Wijns W, Onuma Y, Serruys PW. Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study. BMJ Open. 2020 Dec 10;10(12):e038152. doi: 10.1136/bmjopen-2020-038152.
- Individual participant dataSharing planned: Yes. The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy. Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by National University of Ireland, Galway, Ireland at 3 sites in 3 countries.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hideyuki Kawashima, MD (+353870696945, h.kawashima429@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility expressed in percentage of CABG planning and execution solely based on coronary CTA in 114 candidates for CABG (i.e. the 'CTA heart team' and the operator being blind for the ICA). [percentage/rate]. (time frame: 2 weeks after enrollment). The study lists 2 primary outcomes in all. 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 NCT04142021, which also lists 5 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 26 Apr 2022.