Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

Coronary Artery Disease Clinical Trial

Official title:

Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437965
• Other study ID #: 2021-ZX50
• Status: Recruiting
• Start date: June 3, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Hong Jian Wang, Dr.
• Phone: 008613910008985
• Email: hongjian.wang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Coronary Artery Disease

Intervention

Drug:
• glucocorticoid and immunosuppressants
This study will include patients with isolated coronary arteritis, whose condition could not be controlled by current clinical treatment. After Multiple Disciplinary Team consultation, these patients may be given glucocorticoid and immunosuppressants.

Locations

Country	Name	City	State
China	Jia Lei	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of isolated coronary arteritis	Find some specific cells or cytokines to early diagnosis of isolated coronary arteritis	1 year