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

NCT04320017 | Completed

• 1 other identifier: CIC1421-20-05
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Myocardial Injury; Myocarditis

Keywords

Coronavirus; Heart conditions; Cardio-vascular outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Description of cardiovascular outcomes in the cohort

  During hospital admission (up to 20 days)

• Prognosis role of baseline cardio-vascular caracteristics on patients survival

  1st day of admission

• Prediction of cardio-vascular events with baseline characteristics

  Baseline on first day of admission

• 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 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 Arms (1)

COVID-19 patients

Patients diagnosed with COVID-19 by PCR done on nasal sample.

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

Interventions

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

COVID-19 patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

Clinical Investigation Center Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 33966886 DERIVED

MeSH Terms

Conditions

COVID-19; Myocarditis; Coronavirus Infections

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Investigations in Clinical Investigation Centers Paris-Est

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 20, 2020
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

FR (1)