Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Arteritis
• Intervention / Treatment: Drug: glucocorticoid and immunosuppressants

• Study Type: Observational
• Enrollment (Anticipated): 248

Contacts and Locations

• Study Contact: Name: Hong Jian Wang, Dr.; Phone Number: 008613910008985; Email: hongjian.wang@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 0086
      • Recruiting
      • Jia Lei
      • Contact: Lei Jia, Doctor; Phone Number: 008615001268624; Email: jialei27@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
coronary artery disease
isolated coronary arteritis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of isolated coronary arteritis	Find some specific cells or cytokines to early diagnosis of isolated coronary arteritis	1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: biomarker; inflammation; coronary arteritis
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vasculitis; Coronary Disease; Coronary Artery Disease; Arteritis; Physiological Effects of Drugs; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunosuppressive Agents; Glucocorticoids
• Other Study ID Numbers: 2021-ZX50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study protocol, clinical study report can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No