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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment made by experienced clinicians

    Other intervention

    Treatment made by experienced clinicians

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR)1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Peking Union Medical College Hospital

Collaborator