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

Cardiovascular Diseases Clinical Trial

— SYNTAX III  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813473
• Other study ID #: ECRI-004
• Status: Completed
• Start date: June 27, 2016
• Est. completion date: March 26, 2018

Study information

• Verified date: August 2019
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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;

2. 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;

3. Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;

4. 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;

• 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);

5. All anatomical SYNTAX Scores are eligible;

6. 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);

7. 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;

Exclusion Criteria:

1. Under the age of 18 years;

2. Unable to give Informed Consent;

3. 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;

4. Prior PCI or CABG; history of coronary stent implantation;

5. 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;

6. Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement);

7. Single or two-vessel disease (at time of Heart Team consensus);

8. Atrial fibrillation or significant arrhythmias;

9. Known allergy to iodinated contrast;

10. A Body Mass Index (BMI) of 35 or greater;

11. Participation in another trial with an investigational drug or device.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Heart Diseases
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Radiation:
• Coronary Angiography
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) scan
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

Locations

Country	Name	City	State
Belgium	BE006	Brussel
France	FR013	Nancy
France	FR012	Paris
Germany	DE011	Jena
Italy	IT008	Milan
Switzerland	CH003	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	GE Healthcare, HeartFlow, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Nov 2017
Secondary	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.	Nov 2017
Secondary	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.	Nov 2017
Secondary	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.	Nov 2017
Secondary	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.	Nov 2017
Secondary	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.	Nov 2017
Secondary	Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening	Analysis has not been done.	Nov 2017
Secondary	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.	Nov 2017
Secondary	CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening	Analysis has not been done.	Nov 2017
Secondary	Concordance in SYNTAX Score(s) Between and Within Strategies at Screening	Analysis has not been done.	Nov 2017
Secondary	Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening	Analysis has not been done.	Nov 2017