COVID 19 Infected ST-Elevation Myocardial lnfarction in INDIA (COSTA INDIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- 1.To find out differences in the composite of in-hospital mortality, heart failure, shock, stroke and systemic embolizations in COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period.
研究概览
简要总结
This is a multicentric retrospective cross-sectional study of all consecutive COVID-19 infected STEMI patients admitted during the period May 1st, 2020 to, December 31st 2020 in selected hospitals across India. 40 -50 hospitals that have treated at least five COVID-19 infected STEMI patients will be identified. The hospitals should have proper medical record systems to enable retrieval of data like demography, co-morbid conditions, clinical presentation, medical treatment, reperfusion methods, presentation, clinical course and, management of COVID-19 infection along with outcomes of STEMI. They should also be able to provide the data of patients with age and sex-matched COVID-19 free STEMI patients treated in the same period for the control arm. The comparator population will be age and sex-matched COVID-19 free STEMI patients treated during the same time period in a two to one ratio. Categorical variables will be reported as frequencies and percentages. Continuous variables will be expressed as mean and standard deviation. Clinical and demographic variables will be reported using mean +/- SD or as median when appropriate. Continuous and categorical variables will be assessed using appropriate tests and P-value >.05 will be considered statistically significant.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients above the age of 18 years with STEMI or with new LBBB on 12 lead ECG and diagnosed as acute myocardial infarction (MI) as per the fourth universal definition of MI and COVID-19 positive.
- •The cases could be STEMI patients shown to be COVID-19 positive during routine screening after admission or referred from elsewhere as COVID positive or STEMI developing in the hospital after admission for treatment of COVID 19 infection.
- •COVID-19 infection should be confirmed with RTPCR / Truenat / CBnat / rapid antigen test.
- •Age and sex-matched STEMI patients who are COVID negative will be enrolled as the control group for comparison in a 2:1 ratio.
排除标准
- •patients below the age of 18 years Patients with STEMI who are COVID-19 negative.
结局指标
主要结局
1.To find out differences in the composite of in-hospital mortality, heart failure, shock, stroke and systemic embolizations in COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period.
时间窗: This nationwide retrospective observational study on the clinical presentation, clinical course, and in-hospital outcomes of COVID-infected STEMI patients admitted during the period May 1st, 2020 to December 31 st, 2020.
2. To find out changes in the management strategies of COVID-infected STEMI patients compared to non-infected age and sex-matched STEMI controls treated during the same period.
时间窗: This nationwide retrospective observational study on the clinical presentation, clinical course, and in-hospital outcomes of COVID-infected STEMI patients admitted during the period May 1st, 2020 to December 31 st, 2020.
次要结局
- 1. In-hospital mortality in COVID 19 infected STEMI patients(2. Incidence of stroke or systemic embolization in COVID infected STEMI patients)