Risk Stratification Value of Biomarkers in Patients With Myocarditis

Myocarditis Clinical Trial

— FORWARD  

Official title:

Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010199
• Other study ID #: XJTU1AF2023LSK-169
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: August 31, 2030

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2030
• Est. primary completion date: July 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the incidence of all-cause death	All-cause death diagnosed by clinical doctors will be assessed from the medical records	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Secondary	Change in the incidence of myocardial infarction	Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Secondary	Change in the incidence of stroke	Stroke diagnosed by clinical doctors will be assessed from the medical records	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Secondary	Change in the incidence of coronary revascularization surgery	Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.