NCT02813473

Brief 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. 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

June 15, 2016

Results QC Date

July 16, 2019

Last Update Submit

August 27, 2019

Conditions

Coronary Artery DiseasesMultivessel Coronary Artery DiseaseHeart DiseasesCardiovascular Diseases

Keywords

SYNTAX Score IIMulti Slice Computed TomographyMSCTHeart TeamFractional Flow Reserve Computed TomographyFFRFFR MSCTPCICABGPercutaneous Coronary InterventionCoronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    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

    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

    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

    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

    Nov 2017

  • +6 more secondary outcomes

Interventions

Coronary AngiographyRADIATION

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.

Also known as: Angiogram, Coronary angiogram
Computed Tomography (CT) scanRADIATION

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

Also known as: Cardiac computed tomography, Multi-Slice CT scan (MSCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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;
  • 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;
  • 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;

You may not qualify if:

  • 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);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

BE006

Brussels, Belgium

Location

FR013

Nancy, France

Location

FR012

Paris, France

Location

DE011

Jena, Germany

Location

IT008

Milan, Italy

Location

CH003

Zurich, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 31833413DERIVED

  • Collet 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.

    PMID: 30312411DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Ron van Amsterdam
Organization
ECRI
RvAmsterdam@cardialysis.nl
+31102062802

Study Officials

  • Patrick W Serruys, Prof.

    Imperial College, London (UK)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 27, 2016

Study Start

June 27, 2016

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

September 27, 2019

Results First Posted

September 27, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

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.

Locations

BE(1)CH(1)FR(2)DE(1)IT(1)