N/A
Completed N=223
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
Coronary Artery Diseases · Multivessel Coronary Artery Disease · Heart Failure · Cardiovascular Disease
Source: ClinicalTrials.gov NCT02813473 ↗
Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm. — 0.82 proportion of agreement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm. |
0.82 | — |
| 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. |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| 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 |
— | — |
| SECONDARY Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening |
— | — |
| SECONDARY Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening |
— | — |
| SECONDARY Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening |
— | — |
| SECONDARY CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening |
— | — |
| SECONDARY Concordance in SYNTAX Score(s) Between and Within Strategies at Screening |
— | — |
| SECONDARY Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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;
- 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);
- 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;
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02813473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.