Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

• Conditions: Fulminant Myocarditis

• Registration Number: NCT03268642
• Lead Sponsor: Tongji Hospital

Brief Summary

This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 16 years of age or older;

• Diagnosed as fulminant myocarditis:

  • Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
  • Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
  • Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) < 45%;
  • Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure < 70mm Hg or a systolic blood pressure decrease > 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.

Exclusion Criteria

• Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
• Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
• Unstable hemodynamics or shock caused by hypovolemia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death or cardiac transplantation	through hospital discharge, an average of 10 days	The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China