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Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

Assesment of Clinical Therapeutic Efficacy of Life-support Based Comprehensive Treatment Regimen for Adult Fulminant Myocarditis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03268642
Enrollment
150
Registered
2017-08-31
Start date
2016-02-01
Completion date
2021-12-31
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fulminant Myocarditis

Keywords

Fulminant Myocarditis, Retrospective cohort study

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.

Interventions

None listed

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
death or cardiac transplantationthrough hospital discharge, an average of 10 daysThe 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.

Countries

China

Contacts

Primary ContactYang Sun, MD candidate
d201578301@hust.edu.cn86-27-83663280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026