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 Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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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Study Design
Outcome Measures
Primary Outcome Measures
- Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm. [Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment]
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).
Secondary Outcome Measures
- 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. [Nov 2017]
Analysis has not been done.
- 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 [Nov 2017]
Analysis has not been done.
- 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 [Nov 2017]
Analysis has not been done.
- 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 [Nov 2017]
Analysis has not been done.
- 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 [Nov 2017]
Analysis has not been done.
- Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening [Nov 2017]
Analysis has not been done.
- Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening [Nov 2017]
Analysis has not been done.
- Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening [Nov 2017]
Analysis has not been done.
- CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening [Nov 2017]
Analysis has not been done.
- Concordance in SYNTAX Score(s) Between and Within Strategies at Screening [Nov 2017]
Analysis has not been done.
- Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening [Nov 2017]
Analysis has not been done.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BE006 | Brussel | Belgium | ||
| 2 | FR013 | Nancy | France | ||
| 3 | FR012 | Paris | France | ||
| 4 | DE011 | Jena | Germany | ||
| 5 | IT008 | Milan | Italy | ||
| 6 | CH003 | Zurich | Switzerland |
Sponsors and Collaborators
- ECRI bv
- GE Healthcare
- HeartFlow, Inc.
Investigators
- Principal Investigator: Patrick W Serruys, Prof., Imperial College, London (UK)
Study Documents (Full-Text)
More Information
Publications
None provided.- ECRI-004
Study Results
Participant Flow
| Recruitment Details | 223 patients with presence of 3 vessel dissease or left-main disease were enrolled in 6 centers in Europe to assess the coronary artery disease of the 223 patients randomized with either coronary CTA or conventional angiography blinded to the other modality. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients With Left Main or 3 Vessel Artery Disease |
|---|---|
| Arm/Group Description | 223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an "Angio-First" or a "CT-First" decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint. |
| Period Title: Overall Study | |
| STARTED | 223 |
| COMPLETED | 223 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Patients With Left Main or 3 Vessel Artery Disease |
|---|---|
| Arm/Group Description | Patients with left main or three-vessel coronary artery disease, diagnosed with either coronary CTA or conventional angiography and candidates for either CABG or PCI. |
| Overall Participants | 223 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
67.6
(8.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
35
15.7%
|
| Male |
188
84.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm. |
|---|---|
| Description | 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). |
| Time Frame | Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients With Left Main or 3 Vessel Artery Disease |
|---|---|
| Arm/Group Description | 223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an "Angio-First" or a "CT-First" decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint. |
| Measure Participants | 223 |
| Number (95% Confidence Interval) [proportion of agreement] |
0.82
|
| Title | 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. |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Concordance in SYNTAX Score(s) Between and Within Strategies at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening |
|---|---|
| Description | Analysis has not been done. |
| Time Frame | Nov 2017 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse events were assessed during patient participation in the study which started when informed consent was signed and ended when MSCT was done (if not available at the time of enrollment). That was between 1 and 5 days (max) from enrollement date. | |
|---|---|---|
| Adverse Event Reporting Description | Patient participation started when informed consent was signed untill MSCT was done (if not available at the time of enrollment) between 1 and 5 days (max). Adverse events were collected in the study from first patient in until last patient MSCT that means 1 year and 8 months. | |
| Arm/Group Title | Patients With Left Main or 3 Vessel Artery Disease | |
| Arm/Group Description | Patients with left main or three-vessel coronary artery disease, diagnosed with either coronary CTA or conventional angiography and candidates for either CABG or PCI. | |
All Cause Mortality |
||
| Patients With Left Main or 3 Vessel Artery Disease | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/223 (0%) | |
Serious Adverse Events |
||
| Patients With Left Main or 3 Vessel Artery Disease | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/223 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Patients With Left Main or 3 Vessel Artery Disease | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/223 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ron van Amsterdam |
|---|---|
| Organization | ECRI |
| Phone | +31102062802 |
| RvAmsterdam@cardialysis.nl |
- ECRI-004