Clinical trial NCT05437965: Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism
Official title: Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Arteritis
Keywords: coronary arteritis
biomarker
inflammation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-06-29
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include 45 patients in the isolated coronary arteritis group and 180 patients in the coronary artery disease group. Assuming that the abscission rate of the subjects is 10%, the sample size is 248.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biomarkers of isolated coronary arteritis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jia Lei
state: Beijing
Study officials:
References: