Cardiovascular Diseases Clinical Trial
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.
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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