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NCT Number: NCT06010199

Risk Stratification Value of Biomarkers in Patients With Myocarditis

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.

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in the incidence of MACCE

    Time frame: 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 MACCE will be assessed from the medical records.

Secondary outcomes

  1. Change in the incidence of all-cause death

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guoliang Li

CONTACT

[email protected]

+8613759982523

Yang Yan

CONTACT

[email protected]

+8613259882601

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: FORWARD

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 24, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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