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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-27

Study Completion Date

2018-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of 3D Rotational Angiography After EVAR

NCT02894749

Radiation Burn Aortic Aneurysm, Abdominal

WITHDRAWN NA

The Pivotal Study of the Aptus Endovascular AAA Repair System

NCT00507559

Abdominal Aortic Aneurysms (AAA)

COMPLETED NA

Validation of a Software and the Follow-up of Anteropoterior Migration of Stent

NCT05287828

Aortic Aneurysm

COMPLETED

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

NCT03680742

Intracranial Aneurysm

COMPLETED NA

Study on the Trans-Carotid Artery Occlusion Shunt System

NCT06924593

Revascularization Carotid Artery Stenosis Carotid Artery Diseases

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Diseases Multivessel Coronary Artery Disease Heart Diseases Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

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

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Angiogram Coronary angiogram Cardiac computed tomography Multi-Slice CT scan (MSCT)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No