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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

NCT02813473 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2019-09-27

Study results available
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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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • HeartFlow, Inc.

    collaborator INDUSTRY

  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • Patrick W Serruys, Prof. · Imperial College, London (UK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-27
Primary Completion
2018-03-26
Completion
2018-03-26

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813473 on ClinicalTrials.gov