跳至主要内容
临床试验/CTRI/2022/04/041892
CTRI/2022/04/041892已完成不适用

Association of electrocardiographic markers with mortality in acute COVID-19 infection in a South Indian population- a mixed cohort study

Yenepoya University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2022年1月5日最近更新:

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))

研究者

申办方类型
Private medical college

研究点 (1)

Loading locations...

相似试验

Unknown
不适用
Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19Covid19Myocardial InjuryCardiovascular DiseasesCardiovascular MorbidityHeart Failure
NCT04624503Humanitas Hospital, Italy500
已完成
不适用
MYocardial DOmmages Related to COVID-19Covid19Non Ischemic Myocardial InjuryMyocardial InfarctionTroponin ElevationMyocarditis
NCT04498065Centre Hospitalier Universitaire Dijon273
已完成
不适用
Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19COVID-19Myocardial InjuryMyocarditis
NCT04320017Groupe Hospitalier Pitie-Salpetriere500
招募中
不适用
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)Ventricular ArrhythmiaInflammatory CardiomyopathyGenetic PredispositionAutoimmunityCardiomyopathiesImmunosuppresionCatheter AblationMyocarditisArrhythmia
NCT06591260Scientific Institute San Raffaele20
招募中
不适用
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic ManagementVentricular ArrythmiaInflammatory CardiomyopathyGenetic PredispositionAutoimmunityCardiomyopathiesImmunosuppressionCatheter AblationMyocarditisArrhythmia
NCT04521790Scientific Institute San Raffaele1,000