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RecruitingNCT06010199FORWARDUpdated Jul 12, 2024

Risk Stratification Value of Biomarkers in Patients With Myocarditis

An observational study in Myocarditis, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
3 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Myocarditis

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Keywords

  • Myocarditis
  • Biomarker
  • Risk stratification
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In context

Myocarditis

164 studies on the registry are indexed under Myocarditis; 71 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 226 across 115 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

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.

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

Secondary outcomes

  1. Change in the incidence of all-cause death

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

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

  2. Change in the incidence of myocardial infarction

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

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

  3. Change in the incidence of stroke

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

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

  4. Change in the incidence of coronary revascularization surgery

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

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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06010199
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Aug 24, 2023
Start date
Aug 25, 2023
Primary completion
Jul 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Jul 12, 2024

Study contacts

Guoliang Li
Contact
liguoliang_med@163.com
+8613759982523
Yang Yan
Contact
yangyan3@xjtu.edu.cn
+8613259882601
Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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