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

NCT ID: NCT05437965

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-03

Study Completion Date

2035-04-01

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Treatment made by experienced clinicians

Intervention Type OTHER

Treatment made by experienced clinicians

Interventions

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Treatment made by experienced clinicians

Treatment made by experienced clinicians

Intervention Type OTHER

Eligibility Criteria

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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 informed consent.

Exclusion Criteria

1. 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.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kefei Dou, MD

Director of the Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jia Lei

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Jian Wang, Dr.

Role: CONTACT

008613910008985

Facility Contacts

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Lei Jia, Doctor

Role: primary

008615001268624

Other Identifiers

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2021-ZX50

Identifier Type: -

Identifier Source: org_study_id

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