Syntax ScoreNCT03068858
Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study
A study testing real-time feedback of SYNTAX score category in people with Syntax Score and Appropriateness, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syntax Score, Appropriateness, Coronary Revascularization
- What is being tested?
- real-time feedback of SYNTAX score category
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,245 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
- Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
- Written informed consent.
Who cannot join
- Have prior CABG;
- Have stage PCI;
- Have no assigned scenario in Chinese appropriate use criteria.
Trial locations and contacts
1 site in 1 country.
China1 site
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown.
Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.
- Conditions
- Syntax Score, Appropriateness, Coronary Revascularization
- Being tested
- real-time feedback of SYNTAX score category
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time feedback of SYNTAX score categoryDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| SYNTAX score category feedback group | Experimental | A real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies. Receives: Diagnostic Test: real-time feedback of SYNTAX score category |
| Controlled group | No intervention | Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate rate of coronary revascularization
Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
Measured: 1 month after study completion
Secondary outcomes (4)
The proportion of inappropriate PCI
Inappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
Measured: 1 month after study completion
The proportion of inappropriate CABG
Inappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
Measured: 1 month after study completion
The proportion of utilizing PCI procedures
The proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients
Measured: 1 month after study completion
The proportion of utilizing CABG procedures
The proportion of patients who undergo coronary artery bypass graft (CABG) among total patients
Measured: 1 month after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startSep 2016
- Primary completionSep 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syntax ScoreStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3,245 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068858
- Sponsor's protocol ID
- 20160826
- Status last verified
- Jun 2018
- First submitted
- 19 Feb 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lin S, Zhang H, Chen SP, Rao CF, Wu F, Zhou FJ, Wang Y, Yan HB, Dou KF, Wu YJ, Tang YD, Xie LH, Guan CD, Xu B, Zheng Z. Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness. Chin Med J (Engl). 2020 Jun 5;133(11):1276-1284. doi: 10.1097/CM9.0000000000000827.
PubMed 32452896
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study
- ClinicalTrials.gov ID
- NCT03068858
- Acronym / sponsor ID
- 20160826
- Conditions
- Syntax Score, Appropriateness, Coronary Revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,245 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown.
Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNTAX score category feedback group | Experimental | Diagnostic Test: real-time feedback of SYNTAX score categoryA real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies. |
| Controlled group | No intervention | –Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
- Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
- Written informed consent.
Key exclusion criteria (3 listed)
- Have prior CABG;
- Have stage PCI;
- Have no assigned scenario in Chinese appropriate use criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time feedback of SYNTAX score category | Diagnostic test | SYNTAX score category feedback group |
Primary outcome
Inappropriate rate of coronary revascularization
Time frame: 1 month after study completion
Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
4 secondary outcomes
The proportion of inappropriate PCI
Time frame: 1 month after study completion
The proportion of inappropriate CABG
Time frame: 1 month after study completion
The proportion of utilizing PCI procedures
Time frame: 1 month after study completion
The proportion of utilizing CABG procedures
Time frame: 1 month after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 32452896Lin S, Zhang H, Chen SP, Rao CF, Wu F, Zhou FJ, Wang Y, Yan HB, Dou KF, Wu YJ, Tang YD, Xie LH, Guan CD, Xu B, Zheng Z. Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness. Chin Med J (Engl). 2020 Jun 5;133(11):1276-1284. doi: 10.1097/CM9.0000000000000827.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time feedback of SYNTAX score category in people with Syntax Score and Appropriateness, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inappropriate rate of coronary revascularization (time frame: 1 month after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.