Appropriate Use CriteriaNCT02880605
Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization
An observational study of Appropriate Use Criteria and Coronary Revascularization, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Coronary revascularization (CR) is increasing rapidly in China and varies significantly in proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently, National Center for Cardiovascular Disease organized experts to release Chinese version appropriate use criteria(C-AUC) for coronary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appropriate Use Criteria, Coronary Revascularization
- How many people
- 11,235 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Oct 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergo elective coronary angiography in department of cardiology in period of study. Patients are written informed consent.
Who may be able to join
- Undergo elective coronary angiography in department of cardiology in period of study
- Written informed consent
Who cannot join
- Age ≤18 years of age
- Illiteracy, vision/audition disorder, cognitive disorder etc
Trial locations and contacts
1 site in 1 country.
About this study
Coronary revascularization (CR) is increasing rapidly in China and varies significantly in proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently, National Center for Cardiovascular Disease organized experts to release Chinese version appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at regulating indications of CR. The criteria is considered to contribute to clinical practices, quality assessment and health insurance policy, however, the validation of C-AUC is unknown.
Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center prospective registry. The investigators will recruit 4000 patients undergoing elective coronary angiography with positive outcome consecutively and collect baseline information. Sequently, one-year follow up will be done to collect the prognose, including death, rehospitalization, medicine, medical compliance and life quality etc. One hand, the investigators will compare the outcomes between different therapies in the same indications according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators will evaluate the rationality of CAD therapy in Beijing by C-AUC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| appropriate in appropriate indications | Not described | |
| inappropriate in appropriate indications | Not described | |
| appropriate in inappropriate indications | Not described | |
| inappropriate in inappropriate indications | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events (MACCE)
death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization
Measured: 1 year
Secondary outcomes (5)
death
Measured: 1 year
recurrent hospitalizations for acute coronary syndrome (ACS)
Measured: 1 year
cerebrovascular event
Measured: 1 year
repeat revascularization
Measured: 1 year
cost for hospitalization
Total cost of hospitalization and rehospitalization for cardiac disease in follow-up time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Appropriate Use CriteriaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,235 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880605
- Sponsor's protocol ID
- 2016-1-4031
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2016
- Last updated
- 19 Oct 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 32452896Lin S, Zhang H, Rao CF, Chen SP, Qiao SB, Yan HB, Dou KF, Wu YJ, Tang YD, Yang XC, Shen ZJ, Liu J, Zheng Z; Beijing Coronary Angiography Registry Collaborative Group. Assessing the association of appropriateness of coronary revascularization and 1-year clinical outcomes for patients with stable coronary artery disease in China. Chin Med J (Engl). 2020 Jan 5;133(1):1-8. doi: 10.1097/CM9.0000000000000592.
PubMed 31923098
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization
- ClinicalTrials.gov ID
- NCT02880605
- Acronym / sponsor ID
- 2016-1-4031
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,235 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Aug 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Coronary revascularization (CR) is increasing rapidly in China and varies significantly in proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently, National Center for Cardiovascular Disease organized experts to release Chinese version appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at regulating indications of CR. The criteria is considered to contribute to clinical practices, quality assessment and health insurance policy, however, the validation of C-AUC is unknown.
Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center prospective registry. The investigators will recruit 4000 patients undergoing elective coronary angiography with positive outcome consecutively and collect baseline information. Sequently, one-year follow up will be done to collect the prognose, including death, rehospitalization, medicine, medical compliance and life quality etc. One hand, the investigators will compare the outcomes between different therapies in the same indications according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators will evaluate the rationality of CAD therapy in Beijing by C-AUC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| appropriate in appropriate indications | – | – |
| inappropriate in appropriate indications | – | – |
| appropriate in inappropriate indications | – | – |
| inappropriate in inappropriate indications | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo elective coronary angiography in department of cardiology in period of study. Patients are written informed consent.
Key inclusion criteria (2 listed)
- Undergo elective coronary angiography in department of cardiology in period of study
- Written informed consent
Key exclusion criteria (2 listed)
- Age ≤18 years of age
- Illiteracy, vision/audition disorder, cognitive disorder etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year
death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization
5 secondary outcomes
death
Time frame: 1 year
recurrent hospitalizations for acute coronary syndrome (ACS)
Time frame: 1 year
cerebrovascular event
Time frame: 1 year
repeat revascularization
Time frame: 1 year
cost for hospitalization
Time frame: 1 year
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 19 Oct 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.
- Derived from this study: PubMed 31923098Lin S, Zhang H, Rao CF, Chen SP, Qiao SB, Yan HB, Dou KF, Wu YJ, Tang YD, Yang XC, Shen ZJ, Liu J, Zheng Z; Beijing Coronary Angiography Registry Collaborative Group. Assessing the association of appropriateness of coronary revascularization and 1-year clinical outcomes for patients with stable coronary artery disease in China. Chin Med J (Engl). 2020 Jan 5;133(1):1-8. doi: 10.1097/CM9.0000000000000592.
- Individual participant dataSharing planned: No
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?
An observational study of Appropriate Use Criteria and Coronary Revascularization, 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 2 inclusion and 2 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 19 Oct 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?
Major adverse cardiac and cerebrovascular events (MACCE) (time frame: 1 year). 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 NCT02880605, which also lists 2 linked publications.
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 19 Oct 2018.