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

Completed

• Conditions: COVID-19; Myocardial Injury; Myocarditis
• Interventions: Diagnostic Test: Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care

• Registration Number: NCT04320017
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients	Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care	Patients diagnosed with COVID-19 by PCR done on nasal sample.

Primary Outcome Measures

Name	Time	Method
Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay	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 Outcome Measures

Name	Time	Method
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)	Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6
Prognosis role of baseline cardio-vascular caracteristics on patients survival	1st day of admission	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
Description of cardiovascular outcomes in the cohort	During hospital admission (up to 20 days)	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
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)	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

Trial Locations

Locations (1)

Clinical Investigation Center Pitié-Salpêtrière; 🇫🇷 Paris, France