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Clinical Trials/CTRI/2021/06/034065
CTRI/2021/06/034065Not yet recruitingNot Applicable

Cardiovascular disease manifestations with special emphasis on myocarditis-in moderate to severe COVID-19 patients undergoing treatment in the ccu of a tertiary care hospital in West Bengal India

Dr Swati Datta1 site in 1 country382 target enrollmentStarted: September 6, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
382
Locations
1
Primary Endpoint
1. Need for mechanical ventilation

Study Overview

Brief Summary

Hospitalized patients admitted with fever, cough, sore throat and/or dyspnoea who will be tested positive for SARS-COV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who will be tested negative for SARS-COV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be de-identified and recorded. Demographic characteristics including age at the time of diagnosis, gender, race and BMI will be collected. Past medical history including CAD, heart failure with reduced or preserved ejection fraction, AF, hypertension, dyslipidemia, DM, smoking status as well as home medication will be abstructed. The name and daily dose of ACE inhibitors or ARB will be recorded. Laboratory values including cardiac enzymes, electrolytes, Haemoglobin and creatinine will be collected. Available EKG and TTEs will be individually reviewed by an independent cardiovascular disease fellow or faculty member. Finally clinical outcomes including need for mechanical ventilation, length of intensive care unit stay, length of hospitalization, arrhythmias, cardiac arrest and in hospital mortality will be abstructed from the electronic charts.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age more than 18 years
  • Laboratory confirmed COVID-19 patients
  • SpO2 less than 94%
  • Patients on different modalities of oxygen therapy
  • Patients with radiologically confirmed pneumonia
  • ARDS or Acute Respiratory Failure Control
  • COVID-19 RTPCR negative 3.

Exclusion Criteria

  • Moribund patient with septicemia with or without multiorgan dysfunction
  • Patient unwilling to participate in the study.

Outcomes

Primary Outcomes

1. Need for mechanical ventilation

Time Frame: Within 28 days from CCU admission

3. Length of hospitalization

Time Frame: Within 28 days from CCU admission

2. Length of CCU stay

Time Frame: Within 28 days from CCU admission

4. Incidence of arrhythmia, cardiac arrest during CCU stay

Time Frame: Within 28 days from CCU admission

5. Final outcome-discharge or death

Time Frame: Within 28 days from CCU admission

Secondary Outcomes

  • All cause mortality(Within 28 days from CCU admission)

Investigators

Sponsor
Dr Swati Datta
Sponsor Class
Other [individual]

Study Sites (1)

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