Association of electrocardiographic markers with mortality in acute COVID-19 infection in a South Indian population- a mixed cohort study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Identification of markers of mortality on the 12-lead, resting, surface electrocardiogram
研究概览
简要总结
COVID-19 infection causes myocarditis and the pathophysiology of this remains largely unknown. Myocarditis significantly contributes to morbidity and mortality in COVID-19. These clinical changes show up on the ECG. There is very little evidence on direct myocardial damage, on a 12-lead electrocardiogram (ECG), despite several studies indicating myocardial injury and rise of troponin levels in hospitalized patients. Lampert et al. (2021) retrospectively studied the ECGs of hospitalized patients with COVID-19 at the Mount Sinai Hospital, New York. The authors observed that the diminished QRS (LoQRS) amplitude on the ECG preceded clinical decompensation, culminating in death. There are very few reports from India on ECG as a prognostic indicator of death in COVID-19.
We propose to identify markers in a resting, 12-lead, surface electrocardiogram in adult acute COVID-19 patients during their admission in a hospital that help in prognosticating short-term mortality and to correlate these ECG prognostic parameters with selected demographic variables (age, gender, BMI, existence of comorbidities), using a mixed cohort (retrospective and prospective) observational study. For the retrospective cohort, 300 case records (150 expired and 150 survivors) of adult patients admitted to COVID ward of Yenepoya Medical College Hospital (YMCH) during the secsond wave of the COVID pandemic (from April 2021 to July 2021) will be retrieved and studied. For the prospective cohort, to validate our findings, we will show that the ECG findings from the retrospective cohort is applicable in 10% of our sample size. From March 2022 to April 2022, the first 30 adult patients admitted to the COVID ward at YMCH will be included. Participants who are terminally ill and not expected to survive 24-48 hours after admission will be excluded.
A whole group analysis will be performed and the data would be divided into 2 groups based on which the ECG parameters will be studied (participants who expired within 14 days of admission versus those who survived the same period). Student T- test will be performed for comparing these two groups. Thereafter the Odds-Ratio (OR) will be calculated for all the parameters by the SPSS software.
Along with predicting short-term mortality, the ECG prognostic markers found through this study may give some insight into the unknown pathophysiology of myocarditis caused by COVID-19 which may further serve to formulate a more robust approach to managing complications of the SARS-CoV-2 infection.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •For the Retrospective Cohort: Medical records of adult COVID-19 patients admitted to COVID ward of Yenepoya Medical College Hospital, which have records of the RT-PCR positive report, clinical stage at admission, the clinical outcome at discharge, and 2 clear ECG tracings, will be included.
- •For the prospective cohort: Adult COVID-19 positive patients admitted to Yenepoya Medical College & Hospital.
排除标准
- •For the retrospective cohort: No exclusion criteria For the prospective cohort: Adult COVID-19 positive patients who are terminally ill and not expected to survive 24 hours.
结局指标
主要结局
Identification of markers of mortality on the 12-lead, resting, surface electrocardiogram
时间窗: Day 1 | Day 3
次要结局
- Correlation with demographic variables like age, gender and BMI(14 day clinical outcome (expired or survived))
