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

NCT05437965 | Recruiting

• 1 other identifier: 2021-ZX50
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

coronary arteritis; biomarker; inflammation

Outcome Measures

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.

  10 year

Study Arms (1)

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

Other: Treatment made by experienced clinicians

Interventions

Treatment made by experienced clinicians OTHER

Treatment made by experienced clinicians

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• 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

Study Sites (1)

Jia Lei

Beijing, Beijing Municipality, 0086, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Arteritis; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Vasculitis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hong Jian Wang, Dr.

CONTACT

008613910008985; hongjian.wang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Internal Medicine

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: June 3, 2020
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)