Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

Recruiting

• Conditions: Coronary Artery Disease; Arteritis
• Interventions: Drug: glucocorticoid and immunosuppressants

• Registration Number: NCT05437965
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

The design of this study is generally divided into two parts: First, establish an isolated coronary arteritis cohort. Then, through the case-control study, the clinical characteristics of patients with isolated coronary arteritis and patients with coronary artery disease are compared and the preliminary screening criteria for patients are constructed. Then, through mass spectrometry flow cytometry and cytokine detection, the biomarkers related to immune inflammation related to the occurrence of coronary artery disease are discussed to provide clues for further exploring the pathogenesis; Subsequently, a prospective cohort study was conducted to compare the clinical characteristics and biomarkers of patients with or without adverse cardiovascular events by following up patients with coronary inflammation, and to explore the prognostic factors of patients with coronary inflammation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-03
• Status Verified: 2022-06
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

isolated coronary arteritis group inclusion criteria

1. Age ≥ 18 and ≤ 75;
2. Patients with coronary heart disease, complete revascularization, standardized medication, and repeated hospitalization for myocardial infarction or ischemia within 1 year.
3. Coronary angiography showed coronary artery stenosis or occlusion.
4. The patient (or legal guardian) is fully informed of the test process and signs the informed consent form.

coronary artery disease group inclusion criteria

1. Age ≥ 18 and ≤ 75;
2. Patients with coronary heart disease (at least one vessel underwent coronary stent implantation) and regular medication.
3. No hospitalization with myocardial infarction or ischemia drive occurred within 1 year.
4. The patient (or legal guardian) is fully informed of the test process and signs the informed consent form.

Exclusion Criteria

1. The patient has the following conditions:

   1. Have other serious diseases (malignant tumor, heart failure, etc.), and the life expectancy is less than 12 months;
   2. The patient has known rheumatic immune diseases such as systemic lupus erythematosus, Takayasu arteritis, Behcet's disease, nodular polyarteritis, Wegener granuloma, eosinophil arteritis, giant cell arteritis, rheumatoid arthritis and immunoglobulin G4 related diseases;
   3. Variant angina pectoris;
   4. Coronary artery dissection;
   5. Thrombophilia;
   6. Incomplete expansion of stent;

2. Mental illness;

3. Failure to complete the expected study follow-up for any known reason;

4. The investigator judged that it was not suitable for the enrolled patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
isolated coronary arteritis	glucocorticoid and immunosuppressants	-

Primary Outcome Measures

Name	Time	Method
Biomarkers of isolated coronary arteritis	1 year	Find some specific cells or cytokines to early diagnosis of isolated coronary arteritis

Trial Locations

Locations (1)

Jia Lei; 🇨🇳 Beijing, Beijing, China