Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

Study Overview
=================
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.

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

Conditions
-----------------
Fulminant Myocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Life-support Based Comprehensive Treatment Regimen group<br>meet all the following conditions: intravenous immune globulin; large dose of glucocorticoids; mechanical ventilation; hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO); continuous renal replacement therapy. | |
| conventional therapy group<br>meet one of the following conditions: without/insufficient intravenous immune globulin; without/with various doses of glucocorticoid ; vasoactive drug; without/delayed mechanical ventilation; without/delayed hemodynamic support; without/delayed continuous renal replacement therapy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death or cardiac transplantation | 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. | through hospital discharge, an average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fulminant Myocarditis, Retrospective cohort study