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Clinical Trials/NCT04320017
NCT04320017
Completed
Not Applicable

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-19

Groupe Hospitalier Pitie-Salpetriere1 site in 1 country500 target enrollmentMarch 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Groupe Hospitalier Pitie-Salpetriere
Enrollment
500
Locations
1
Primary Endpoint
Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Cases of myocarditis have also been reported with COVID-19.

Cardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.We will also assess predictive factors for transfer in Intensive Care Unit or death.

Registry
clinicaltrials.gov
Start Date
March 20, 2020
End Date
July 20, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible Party
Principal Investigator
Principal Investigator

Joe Elie Salem

Head of Investigations in Clinical Investigation Centers Paris-Est

Groupe Hospitalier Pitie-Salpetriere

Eligibility Criteria

Inclusion Criteria

  • COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples

Exclusion Criteria

  • Patients who refused the use of their routine care data after information by investigators.

Outcomes

Primary Outcomes

Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay

Time Frame: ECG and concomitant troponine at day 1 after admission at day 1, day 3 day 6 the first week after admission, and then at day 14 and before the patient is discharged (up to 20 days)

Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography

Secondary Outcomes

  • Characterization of inflammation on cardio-vascular outcomes(Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days))
  • Prognosis role of baseline cardio-vascular caracteristics on patients survival(1st day of admission)
  • Description of cardiovascular outcomes in the cohort(During hospital admission (up to 20 days))
  • Prediction of cardio-vascular events with baseline characteristics(Baseline on first day of admission)
  • Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival(Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days))

Study Sites (1)

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