Status:
UNKNOWN
Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis
Lead Sponsor:
Tongji Hospital
Conditions:
Fulminant Myocarditis
Eligibility:
All Genders
16+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03268642
Start Date
February 1 2016
End Date
December 1 2021
Last Update
March 12 2020
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030