Risk Stratification Value of Biomarkers in Patients With Myocarditis

NCT06010199 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-169
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.

Conditions

Myocarditis

Keywords

Myocarditis; Biomarker; Risk stratification

Outcome Measures

Primary Outcomes (1)

• Change in the incidence of MACCE

  MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACCE will be assessed from the medical records.

  1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.

Secondary Outcomes (4)

• Change in the incidence of all-cause death

  1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.

• Change in the incidence of myocardial infarction

  1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.

• Change in the incidence of stroke

  1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.

• Change in the incidence of coronary revascularization surgery

  1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.

Study Arms (1)

Myocarditis group

All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition.

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hospitalized patients who meet the diagnostic criteria for myocarditis and undergo regular follow-up at the corresponding cardiovascular center are included in the study.

You may qualify if:

• All patients should meet the diagnostic criteria for myocarditis
• Patients who are regularly followed up at the corresponding cardiovascular center

You may not qualify if:

• Age \<3 years or \>80 years
• Pregnant or lactating women
• The patient refused to sign the informed consent and refused to participate in the study
• None of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. Depending on the condition, the patient may not wake up to sign the informed consent

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, feces.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

+8613759982523; liguoliang_med@163.com

Yang Yan

CONTACT

+8613259882601; yangyan3@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 24, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: July 12, 2024

Record last verified: 2024-03

Locations

CN (1)