Clinical trial NCT06010199: Risk Stratification Value of Biomarkers in Patients With Myocarditis
Official title: Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis
Keywords: Myocarditis
Biomarker
Risk stratification
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the incidence of MACCE
timeFrame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Secondary outcomes:
measure: Change in the incidence of all-cause death
timeFrame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
measure: Change in the incidence of myocardial infarction
timeFrame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
measure: Change in the incidence of stroke
timeFrame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
measure: Change in the incidence of coronary revascularization surgery
timeFrame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
References: