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FORWARD: Risk Stratification Value of Biomarkers in Patients With Myocarditis

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010199
Collaborator
(none)
1,000
Enrollment
1
Location
84
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
    Anticipated Study Start Date :
    Aug 31, 2023
    Anticipated Primary Completion Date :
    Aug 31, 2030
    Anticipated Study Completion Date :
    Aug 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in the incidence of MACE [1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]

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

    Secondary Outcome Measures

    1. Change in the incidence of all-cause death [1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]

      All-cause death diagnosed by clinical doctors will be assessed from the medical records

    2. Change in the incidence of myocardial infarction [1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]

      Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records

    3. Change in the incidence of stroke [1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]

      Stroke diagnosed by clinical doctors will be assessed from the medical records

    4. Change in the incidence of coronary revascularization surgery [1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]

      Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients should meet the diagnostic criteria for myocarditis

    • Patients who are regularly followed up at the corresponding cardiovascular center

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University

    Investigators

    • Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University
    • Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT06010199
    Other Study ID Numbers:
    • XJTU1AF2023LSK-169
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
    Myocarditis
    Biomarker
    Risk stratification
    Additional relevant MeSH terms:
    Myocarditis

    Study Results

    No Results Posted as of Aug 24, 2023