Clinical trial NCT04320017: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Myocardial Injury
Myocarditis
Keywords: Coronavirus
Heart conditions
Cardio-vascular outcomes
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in Pitié-Salpêtrière hospital will be eligible, if the electrocardiogram and the transthoracic echocardiography is technically feasible.

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.


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.

Primary outcomes:
measure: Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay
timeFrame: 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)
Secondary outcomes:
measure: Description of cardiovascular outcomes in the cohort
timeFrame: During hospital admission (up to 20 days)
measure: Prognosis role of baseline cardio-vascular caracteristics on patients survival
timeFrame: 1st day of admission
measure: Prediction of cardio-vascular events with baseline characteristics
timeFrame: Baseline on first day of admission
measure: Characterization of inflammation on cardio-vascular outcomes
timeFrame: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
measure: Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival
timeFrame: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Investigation Center Pitié-Salpêtrière
Study officials:
References:
citation: Fenioux C, Allenbach Y, Vozy A, Salem JE, Maalouf G, Vieira M, Le Joncour A, Benveniste O, Saadoun D, Frere C, Campedel L, Salem P, Gligorov J, Funck-Brentano C, Cacoub P, Gougis P. [Differences of characteristics and outcomes between cancer patients and patients with no active cancer hospitalised for a SARS-CoV-2 infection]. Bull Cancer. 2021 Jun;108(6):581-588. doi: 10.1016/j.bulcan.2021.03.004. Epub 2021 Mar 20. French.