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RecruitingNCT05437965RECUR RegistryUpdated Aug 8, 2025

National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis

An observational study in Coronary Artery Disease, Arteritis and In-Stent Stenosis (Restenosis) of Coronary Artery Stent, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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 Coronary Unexplained in-stent Restenosis (RECUR).

02

Conditions studied

  • Coronary Artery Disease
  • Arteritis
  • In-Stent Stenosis (Restenosis) of Coronary Artery Stent

Keywords

  • coronary arteritis
  • biomarker
  • inflammation
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In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years;
  2. Patients meeting the diagnostic criteria for Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR);
  3. Patients fully informed about the trial procedures who provide written .

Exclusion criteria

Exclusion Criteria:

  1. Patients presenting with any of the following:

    • Other severe comorbidities (e.g., malignant tumors, heart failure) with a \<12 months;

      • Known /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;

              • Stent underexpansion.
  2. Presence of psychiatric disorders;
  3. Known inability to complete expected study follow-up for any reason;
  4. Patients deemed ineligible for enrollment by the investigator.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR)

    Other: Treatment made by experienced clinicians

Interventions

  • OtherTreatment made by experienced clinicians

    Treatment made by experienced clinicians

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 year

07

Study locations

1 of 1 sites recruiting
  • Jia Lei
    Beijing, Beijing Municipality 0086, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Study protocol, clinical study report can be shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05437965
Responsible party
Kefei Dou, MD (Director of the Department of Internal Medicine, China National Center for Cardiovascular Diseases) — Principal investigator
First posted
Jun 29, 2022
Start date
Jun 3, 2020
Primary completion
Apr 1, 2035 (estimated)
Completion
Apr 1, 2035 (estimated)
Last update
Aug 8, 2025

Study contacts

Hong Jian Wang, Dr.
Contact
hongjian.wang@gmail.com
008613910008985

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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