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

COVID-19 Clinical Trial

— JOCOVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320017
• Other study ID #: CIC1421-20-05
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: July 20, 2020

Study information

• Verified date: January 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Myocardial Injury
• Myocarditis

Intervention

Diagnostic Test:
• Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care
12 derivations electrocardiogram done at baseline and repeated every 3 days transthoracic echocardiography at baseline clinical features at baseline: WHO performans status comorbidities and treatments biological results in routine care, such as baseline full blood count, inflammation markers: C-reactive protein, procalcitonin, interleukin-6 and ferritin, coagulation and troponin and brain natriuretic peptide

Locations

Country	Name	City	State
France	Clinical Investigation Center Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay	Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography	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	Description of cardiovascular outcomes in the cohort	Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death	During hospital admission (up to 20 days)
Secondary	Prognosis role of baseline cardio-vascular caracteristics on patients survival	Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling	1st day of admission
Secondary	Prediction of cardio-vascular events with baseline characteristics		Baseline on first day of admission
Secondary	Characterization of inflammation on cardio-vascular outcomes	Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6	Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
Secondary	Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival	clinical features at baseline: WHO performans status comorbidities and treatments Biological markers including but not limited to: full blood count, C reactive protein, procalcitonine, fibrinogen, interleukin-6, troponin and brain natriuretic peptide	Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)