Coronary Artery DiseasesSYNTAX IIINCT02813473
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
An observational study of Coronary Artery Diseases and Multivessel Coronary Artery Disease, run by ECRI bv at 6 sites in 5 countries.
Trial summary
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases
- What is being tested?
- Coronary Angiography and Computed Tomography (CT) scan
- Type of treatment
- Surgery or procedure
- How many people
- 223 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 27 Jun 2016to 26 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 complex coronary artery disease, defined as: left main (isolated, or associated with 1, 2 or 3 vessel disease) or de novo 3-vessel coronary artery disease (DS ≥50%), who are able to undergo cardiac CT with a GE high-definition RevolutionTM multi-slice CT scanner.
Who may be able to join
- Patients with at least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, 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 CX territories may be included in the trial as a 3VD equivalent;
- Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
- Patients with chronic stable angina or stabilized acute coronary syndrome (inclusion criteria of the SYNTAX I study):
- stable (Canadian Cardiovascular Society Class 1, 2, 3 or 4) angina pectoris;
- or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC) angina pectoris and ischemia with normal cardiac enzyme values prior to enrollment;
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- or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography);
- All anatomical SYNTAX Scores are eligible;
- Patient amenable to a MSCT coronary angiography (e.g. no claustrophobia, high heartrate not amenable to beta-blockers, poor renal function, etc., up to discretion of investigator);
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;
Who cannot join
- Under the age of 18 years;
- Unable to give Informed Consent;
- Known pregnancy at time of enrolment. Female of childbearing potential (and last menstruation within the last 12 months), who are not taking adequate contraceptives. Female who is breastfeeding at time of enrolment;
- Prior PCI or CABG; history of coronary stent implantation;
- Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment;
- Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement);
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- Single or two-vessel disease (at time of Heart Team consensus);
- Atrial fibrillation or significant arrhythmias;
- Known allergy to iodinated contrast;
- A Body Mass Index (BMI) of 35 or greater;
- Participation in another trial with an investigational drug or device.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
About this study
Official title: SYNTAX III REVOLUTION Trial: A Randomized Study to Evaluate the Feasibility of Heart-Team Clinical Decision Making Regarding the Optimal (Surgical or Percutaneous Based) Revascularization Strategy in Patients With Complex Coronary Artery Disease, Based on Non-invasive Coronary CT Angiography (CTA) Imaging Utilising High-definition GE RevolutionTM Multi-slice CT and HeartFlow FFRCT Compared to the Current Standard of Care With Conventional Invasive Coronary Angiography (CA)
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Each patient will undergo an angiogram and CT scan per standard of care. The randomization strategy in this study is not between patients but between two teams of doctors, the so-called "Heart Teams", will be randomized: in the first round, team 1 assesses the angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment would be the best to treat complex coronary artery disease. In the second round, both teams see the imaging method that they did not see in the first round, and make the decision again. The final decision on the clinical treatment strategy is at the sole discretion of the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing this final decision.
Hypothesis: Determination of the best treatment strategy for coronary artery disease based on a CT scan will result in similar decisions as based on invasive coronary angiography.
Read the detailed description
The SYNTAX III REVOLUTION Trial is a multicenter, all-comers trial (either isolated unprotected left-main or 3-vessel disease with or without left-main disease and candidate for either CABG or PCI treatment). In SYNTAXIII REVOLUTION a diagnostic coronary angiography and a diagnostic coronary Multislice CT are performed to allow the Heart Team to assess the optimal revascularization strategy. In a normal hospital setting the angiography is considered standard of care. The multislice CT can already also be part of the diagnosis and is at the discretion of the physician. After the images of both modalities are available, the patient will no longer participate in the trial. Next step is randomization of Heart Team A and Heart B to the sequence of availability of images, i.e. randomizing whether Heart Team A will review the angiography first or the multislice CT and, automatically, Heart B the other modality. The Heart Teams need to make a decision between surgical or percutaneous treatment according to either the conventional angiography or the multislice CT angiography assessment. In addition, the incremental value of FFRCT in the decision making of the Heart Team arm allocated primarily to the assessment of the MSCT (CT first algorithm) will be a secondary endpoint. No intervention to the patient's treatment takes place
i
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Being tested
- Coronary Angiography, Computed Tomography (CT) scan
- Keywords
- SYNTAX Score II, Multi Slice Computed Tomography, MSCT, Heart Team, Fractional Flow Reserve Computed Tomography, FFR, FFR MSCT, PCI, CABG, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
- Medical subject headings
- Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyRadiation
Also called Angiogram, Coronary angiogram
Coronary angiography is an X-ray test to diagnose diseases of the arteries that supply blood to the heart. Coronary angiography can detect weakened blood vessel walls and narrowed or blocked vessels. X-rays are taken after a special dye has been injected into the bloodstream, making the vessels and blood flow through the vessels visible on X-rays.
Computed Tomography (CT) scanRadiation
Also called Cardiac computed tomography, Multi-Slice CT scan (MSCT)
A CT scan is an X-ray imaging technique that uses a computer to produce cross-sectional images. It can be used to examine the heart and blood vessels for problems
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm.
Inter-rater agreement, as assessed by Cohen's Kappa Kappa, on revascularization strategy of two Heart Teams using an "Angio-first" algorithm (based on invasive SYNTAX Score II) or a "CT-first" algorithm (based on non-invasive SYNTAX Score II, without FFRCT) and 95% confidence intervals (CI).
Measured: Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment
Secondary outcomes (11)
Level of Agreement in the Decision Making Strategy Based on CT Only Without Functional Assessment and the Decision Making Strategy Based on CT With Functional Assessment ("CT First" Algorithm Group) at Screening.
Analysis has not been done.
Measured: Nov 2017
Level of Agreement in the Decision Making Strategy Based on CT Only (With Functional Assessment) and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography ("CT First" Algorithm Group) at Screening
Analysis has not been done.
Measured: Nov 2017
Level of Agreement in the Decision Making Strategy Based on Conventional Angiography Only and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography ("Angio First" Algorithm Group) at Screening
Analysis has not been done.
Measured: Nov 2017
Inter-rater Agreement on Revascularization Strategy (Based on Conventional Angiography and CT With Functional Assessment) of Two Heart Teams Using an "Angio-first" Algorithm or a "CT-first" Algorithm at Screening
Analysis has not been done.
Measured: Nov 2017
Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Heart Team Involving an Experienced Coronary CT Reader) and the Resulting SYNTAX Score II at Screening
Analysis has not been done.
Measured: Nov 2017
Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening
Analysis has not been done.
Measured: Nov 2017
Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening
Analysis has not been done.
Measured: Nov 2017
Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening
Analysis has not been done.
Measured: Nov 2017
CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening
Analysis has not been done.
Measured: Nov 2017
Concordance in SYNTAX Score(s) Between and Within Strategies at Screening
Analysis has not been done.
Measured: Nov 2017
Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening
Analysis has not been done.
Measured: Nov 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start27 Jun 2016
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseasesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Responsible party
- Sponsor
- Investigators
- Patrick W Serruys, Prof., Principal investigator, Imperial College, London (UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813473
- Sponsor's protocol ID
- ECRI-004
- Acronym
- SYNTAX III
- Status last verified
- Aug 2019
- First submitted
- 15 Jun 2016
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
Andreini D, Modolo R, Katagiri Y, Mushtaq S, Sonck J, Collet C, De Martini S, Roberto M, Tanaka K, Miyazaki Y, Czapla J, Schoors D, Plass A, Maisano F, Kaufmann P, Orry X, Metzdorf PA, Folliguet T, Farber G, Diamantis I, Schonweiss M, Bonalumi G, Guglielmo M, Ferrari C, Olivares P, Cavallotti L, Leal I, Lindeboom W, Onuma Y, Serruys PW, Bartorelli AL; SYNTAX III REVOLUTION Investigators. Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e007607. doi: 10.1161/CIRCINTERVENTIONS.118.007607. Epub 2019 Dec 13.
PubMed 31833413Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.
PubMed 30312411
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNTAX III REVOLUTION Trial: A Randomized Study to Evaluate the Feasibility of Heart-Team Clinical Decision Making Regarding the Optimal (Surgical or Percutaneous Based) Revascularization Strategy in Patients With Complex Coronary Artery Disease, Based on Non-invasive Coronary CT Angiography (CTA) Imaging Utilising High-definition GE RevolutionTM Multi-slice CT and HeartFlow FFRCT Compared to the Current Standard of Care With Conventional Invasive Coronary Angiography (CA)
- ClinicalTrials.gov ID
- NCT02813473
- Acronym / sponsor ID
- SYNTAX III / ECRI-004
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Keywords
- SYNTAX Score II, Multi Slice Computed Tomography, MSCT, Heart Team, Fractional Flow Reserve Computed Tomography, FFR, FFR MSCT, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 27 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Each patient will undergo an angiogram and CT scan per standard of care. The randomization strategy in this study is not between patients but between two teams of doctors, the so-called "Heart Teams", will be randomized: in the first round, team 1 assesses the angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment would be the best to treat complex coronary artery disease. In the second round, both teams see the imaging method that they did not see in the first round, and make the decision again. The final decision on the clinical treatment strategy is at the sole discretion of the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing this final decision.
Hypothesis: Determination of the best treatment strategy for coronary artery disease based on a CT scan will result in similar decisions as based on invasive coronary angiography.
Detailed description
The SYNTAX III REVOLUTION Trial is a multicenter, all-comers trial (either isolated unprotected left-main or 3-vessel disease with or without left-main disease and candidate for either CABG or PCI treatment). In SYNTAXIII REVOLUTION a diagnostic coronary angiography and a diagnostic coronary Multislice CT are performed to allow the Heart Team to assess the optimal revascularization strategy. In a normal hospital setting the angiography is considered standard of care. The multislice CT can already also be part of the diagnosis and is at the discretion of the physician. After the images of both modalities are available, the patient will no longer participate in the trial. Next step is randomization of Heart Team A and Heart B to the sequence of availability of images, i.e. randomizing whether Heart Team A will review the angiography first or the multislice CT and, automatically, Heart B the other modality. The Heart Teams need to make a decision between surgical or percutaneous treatment according to either the conventional angiography or the multislice CT angiography assessment. In addition, the incremental value of FFRCT in the decision making of the Heart Team arm allocated primarily to the assessment of the MSCT (CT first algorithm) will be a secondary endpoint. No intervention to the patient's treatment takes place
i
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complex coronary artery disease, defined as: left main (isolated, or associated with 1, 2 or 3 vessel disease) or de novo 3-vessel coronary artery disease (DS ≥50%), who are able to undergo cardiac CT with a GE high-definition RevolutionTM multi-slice CT scanner.
Key inclusion criteria (10 listed)
- Patients with at least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, 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 CX territories may be included in the trial as a 3VD equivalent;
- Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
- Patients with chronic stable angina or stabilized acute coronary syndrome (inclusion criteria of the SYNTAX I study):
- All anatomical SYNTAX Scores are eligible;
Key exclusion criteria (11 listed)
- Under the age of 18 years;
- Unable to give Informed Consent;
- Known pregnancy at time of enrolment. Female of childbearing potential (and last menstruation within the last 12 months), who are not taking adequate contraceptives. Female who is breastfeeding at time of enrolment;
- Prior PCI or CABG; history of coronary stent implantation;
- Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment;
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 AngiographyAlso: Angiogram, Coronary angiogramCoronary angiography is an X-ray test to diagnose diseases of the arteries that supply blood to the heart. Coronary angiography can detect weakened blood vessel walls and narrowed or blocked vessels. X-rays are taken after a special dye has been injected into the bloodstream, making the vessels and blood flow through the vessels visible on X-rays. | Radiation | – |
| Computed Tomography (CT) scanAlso: Cardiac computed tomography, Multi-Slice CT scan (MSCT)A CT scan is an X-ray imaging technique that uses a computer to produce cross-sectional images. It can be used to examine the heart and blood vessels for problems | Radiation | – |
Primary outcome
Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm.
Time frame: Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment
Inter-rater agreement, as assessed by Cohen's Kappa Kappa, on revascularization strategy of two Heart Teams using an "Angio-first" algorithm (based on invasive SYNTAX Score II) or a "CT-first" algorithm (based on non-invasive SYNTAX Score II, without FFRCT) and 95% confidence intervals (CI).
11 secondary outcomes
Level of Agreement in the Decision Making Strategy Based on CT Only Without Functional Assessment and the Decision Making Strategy Based on CT With Functional Assessment ("CT First" Algorithm Group) at Screening.
Time frame: Nov 2017
Level of Agreement in the Decision Making Strategy Based on CT Only (With Functional Assessment) and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography ("CT First" Algorithm Group) at Screening
Time frame: Nov 2017
Level of Agreement in the Decision Making Strategy Based on Conventional Angiography Only and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography ("Angio First" Algorithm Group) at Screening
Time frame: Nov 2017
Inter-rater Agreement on Revascularization Strategy (Based on Conventional Angiography and CT With Functional Assessment) of Two Heart Teams Using an "Angio-first" Algorithm or a "CT-first" Algorithm at Screening
Time frame: Nov 2017
Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Heart Team Involving an Experienced Coronary CT Reader) and the Resulting SYNTAX Score II at Screening
Time frame: Nov 2017
Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening
Time frame: Nov 2017
Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening
Time frame: Nov 2017
Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening
Time frame: Nov 2017
CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening
Time frame: Nov 2017
Concordance in SYNTAX Score(s) Between and Within Strategies at Screening
Time frame: Nov 2017
Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening
Time frame: Nov 2017
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31833413Andreini D, Modolo R, Katagiri Y, Mushtaq S, Sonck J, Collet C, De Martini S, Roberto M, Tanaka K, Miyazaki Y, Czapla J, Schoors D, Plass A, Maisano F, Kaufmann P, Orry X, Metzdorf PA, Folliguet T, Farber G, Diamantis I, Schonweiss M, Bonalumi G, Guglielmo M, Ferrari C, Olivares P, Cavallotti L, Leal I, Lindeboom W, Onuma Y, Serruys PW, Bartorelli AL; SYNTAX III REVOLUTION Investigators. Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e007607. doi: 10.1161/CIRCINTERVENTIONS.118.007607. Epub 2019 Dec 13.
- Derived from this study: PubMed 30312411Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.
- 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.
Patrick W Serruys, Prof. principal investigator
Imperial College, London (UK)
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Diseases and Multivessel Coronary Artery Disease, run by ECRI bv at 6 sites in 5 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 10 inclusion and 11 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Belgium, Germany, Italy, Switzerland. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm. (time frame: Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment). 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 NCT02813473, which also lists 2 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 27 Sep 2019.