Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- death or cardiac transplantation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
death or cardiac transplantation
时间窗: 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.
次要结局
未报告次要终点
研究者
Dao Wen Wang
Principal Investigator
Tongji Hospital