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CTRI Number  CTRI/2022/04/041892 [Registered on: 18/04/2022] Trial Registered Prospectively
Last Modified On: 25/02/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   ECG markers for mortality prediction in COVID-19 
Scientific Title of Study   Association of electrocardiographic markers with mortality in acute COVID-19 infection in a South Indian population- a mixed cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hana Tabassum 
Designation  MBBS 3rd year Student 
Affiliation  Yenepoya Medical College 
Address  Department of Internal Medicine Yenepoya Medical College Hospital University Road Deralakatte
Department of Internal Medicine Yenepoya Medical College Hospital University Road Deralakatte
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8956919669  
Fax  2203943  
Email  hanatabassum2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ravi Vaswani 
Designation  Professor 
Affiliation  Yenepoya Medical College 
Address  Department of Internal Medicine Yenepoya Medical College University Road Deralakatte Mangalore
University Road Deralakatte Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448858983  
Fax  2203943  
Email  ravi.vaswani@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Ravi Vaswani 
Designation  Professor 
Affiliation  Yenepoya Medical College 
Address  Department of Internal Medicine Yenepoya Medical College University Road Deralakatte Mangalore
University Road Deralakatte Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448858983  
Fax  2203943  
Email  ravi.vaswani@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya University University Road Deralakatte Mangalore 575018 Karnataka 
 
Primary Sponsor  
Name  Yenepoya University 
Address  University Road Deralakatte Mangalore 575018 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ravi Vaswani  Yenepoya Medical College Hospital  Department of Internal Medicine Yenepoya Medical College Deralakatte Mangalore 575018
Dakshina Kannada
KARNATAKA 		 9448858983
2203943
ravi.vaswani@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee - 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of markers of mortality on the 12-lead, resting, surface electrocardiogram  Day 1
Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation with demographic variables like age, gender and BMI  14 day clinical outcome (expired or survived) 
 
Target Sample Size   Total Sample Size="330"
Sample Size from India="330" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2022 
Date of Study Completion (India) 20/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  Report of the findings
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ravi.vaswani@yenepoya.edu.in].

  6. For how long will this data be available start date provided 01-08-2022 and end date provided 31-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   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.
 
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