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Completed

NCT Number: 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

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.

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Key information

Conditions

COVID-19 Cardiomyopathies Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Myocardial Injury Myocarditis Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Investigation Center Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care

Diagnostic Test
  • 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

Primary outcomes

  1. 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

  1. Description of cardiovascular outcomes in the cohort

    Time frame: 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

  2. Prognosis role of baseline cardio-vascular caracteristics on patients survival

    Time frame: 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

  3. Prediction of cardio-vascular events with baseline characteristics

    Time frame: Baseline on first day of admission

  4. Characterization of inflammation on cardio-vascular outcomes

    Time frame: 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

  5. Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: JOCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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