Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT05437965
Collaborator
(none)
248
1
57.9
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: glucocorticoid and immunosuppressants

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
248 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism
Actual Study Start Date :
Jun 3, 2020
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

coronary artery disease

Outcome Measures

Primary Outcome Measures

  1. Biomarkers of isolated coronary arteritis [1 year]

    Find some specific cells or cytokines to early diagnosis of isolated coronary arteritis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  2. Have other serious diseases (malignant tumor, heart failure, etc.), and the life expectancy is less than 12 months;

  3. 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;

  4. Variant angina pectoris;

  5. Coronary artery dissection;

  6. Thrombophilia;

  7. Incomplete expansion of stent;

  8. Mental illness;

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jia Lei Beijing Beijing China 0086

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT05437965
Other Study ID Numbers:
  • 2021-ZX50
First Posted:
Jun 29, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by China National Center for Cardiovascular Diseases
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022