Coronary Artery DiseaseRECUR RegistryNCT05437965
National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
An observational study of Coronary Artery Disease and Arteritis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This project aims to establish a clinical cohort and diagnostic assessment framework by conducting a national multicenter cohort registry study. Through the collection of patients' clinical characteristics, it will achieve the registration, management, follow-up, and analysis of patients with Rapid rEcurrences of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Arteritis, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- What is being tested?
- Treatment made by experienced clinicians
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2020to 1 Apr 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who meet the definition of Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR), that is, patients who have undergone myocardial infarction or target vessel-related revascularization ≥3 times due to coronary artery stenosis in the past year after coronary stent implantation and standard coronary heart disease conventional treatment (complete revascularization and optimal medical therapy), excluding common risk factors for coronary artery restenosis and known rheumatic autoimmune diseases, systemic vasculitis, etc.
Who may be able to join
- Age ≥ 18 years;
- Patients meeting the diagnostic criteria for Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR);
- Patients fully informed about the trial procedures who provide written informed consent.
Who cannot join
- Patients presenting with any of the following:
- Other severe comorbidities (e.g., malignant tumors, heart failure) with a life expectancy <12 months;
- Known autoimmune/rheumatic diseases including systemic lupus erythematosus, Takayasu arteritis, Behçet's disease, polyarteritis nodosa, Wegener granulomatosis (granulomatosis with polyangiitis), eosinophilic arteritis, giant cell arteritis, rheumatoid arthritis, or IgG4-related disease;
- Variant angina (Prinzmetal's angina);
- Coronary artery dissection;
- Thrombophilia;
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- Stent underexpansion.
- Presence of psychiatric disorders;
- Known inability to complete expected study follow-up for any reason;
- Patients deemed ineligible for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jia Lei
Beijing, Beijing Municipality, 0086
Lei Jia, Doctor, 008615001268624, jialei27@126.com
About this study
This project aims to establish a clinical cohort and diagnostic assessment framework by conducting a national multicenter cohort registry study. Through the collection of patients' clinical characteristics, it will achieve the registration, management, follow-up, and analysis of patients with Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR).
- Conditions
- Coronary Artery Disease, Arteritis, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Being tested
- Treatment made by experienced clinicians
- Keywords
- coronary arteritis, biomarker, inflammation
- Medical subject headings
- Coronary Artery Disease, Arteritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment made by experienced cliniciansOther
Treatment made by experienced clinicians
| Study group | Role | What they receive |
|---|---|---|
| Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR) | Not described Receives: Other: Treatment made by experienced clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure
Time to the incidence of target vessel failure, a composite of cardiovascular death, target vessel-related myocardial infarction, and target vessel-related revascularization.
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start3 Jun 2020
- Primary completion1 Apr 2035 (estimated)
- Study completion1 Apr 2035 (estimated)
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 Coronary Artery DiseaseStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437965
- Sponsor's protocol ID
- 2021-ZX50
- Acronym
- RECUR Registry
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, clinical study report can be shared.
Publications
Jia L, Wang K, Lin Z, Yin D, Ren W, Zhang Z, Fang W, Wang L, Dou K. Molecular phenotyping with 18F-FDG and 18F-FAPI PET/CT: advancing risk stratification in in-stent restenosis. Eur J Nucl Med Mol Imaging. 2026 Jul 1. doi: 10.1007/s00259-026-08036-5. Online ahead of print.
PubMed 42380497
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
- ClinicalTrials.gov ID
- NCT05437965
- Acronym / sponsor ID
- RECUR Registry / 2021-ZX50
- Conditions
- Coronary Artery Disease, Arteritis, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Keywords
- coronary arteritis, biomarker, inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, Peking Union Medical College Hospital
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 Apr 2035 (estimated)
- Study completion
- 1 Apr 2035 (estimated)
- First posted
- 29 Jun 2022 (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.
This project aims to establish a clinical cohort and diagnostic assessment framework by conducting a national multicenter cohort registry study. Through the collection of patients' clinical characteristics, it will achieve the registration, management, follow-up, and analysis of patients with Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR) | – | Other: Treatment made by experienced clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the definition of Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR), that is, patients who have undergone myocardial infarction or target vessel-related revascularization ≥3 times due to coronary artery stenosis in the past year after coronary stent implantation and standard coronary heart disease conventional treatment (complete revascularization and optimal medical therapy), excluding common risk factors for coronary artery restenosis and known rheumatic autoimmune diseases, systemic vasculitis, etc.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients meeting the diagnostic criteria for Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR);
- Patients fully informed about the trial procedures who provide written informed consent.
Key exclusion criteria (10 listed)
- Patients presenting with any of the following:
- Presence of psychiatric disorders;
- Known inability to complete expected study follow-up for any reason;
- Patients deemed ineligible for enrollment by the investigator.
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 |
|---|---|---|
| Treatment made by experienced cliniciansTreatment made by experienced clinicians | Other | Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR) |
Primary outcome
Target vessel failure
Time frame: 10 year
Time to the incidence of target vessel failure, a composite of cardiovascular death, target vessel-related myocardial infarction, and target vessel-related revascularization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 42380497Jia L, Wang K, Lin Z, Yin D, Ren W, Zhang Z, Fang W, Wang L, Dou K. Molecular phenotyping with 18F-FDG and 18F-FAPI PET/CT: advancing risk stratification in in-stent restenosis. Eur J Nucl Med Mol Imaging. 2026 Jul 1. doi: 10.1007/s00259-026-08036-5. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Study protocol, clinical study report can be shared.
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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.
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 Coronary Artery Disease and Arteritis, 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 10 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Jian Wang, Dr. (008613910008985, hongjian.wang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (time frame: 10 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 NCT05437965, 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 8 Aug 2025.