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

NCT ID: NCT04320017

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-07-20

Brief Summary

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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

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Conditions

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COVID-19 Myocardial Injury Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 patients

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

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

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Head of Investigations in Clinical Investigation Centers Paris-Est

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Investigation Center Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33966886 (View on PubMed)

Other Identifiers

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CIC1421-20-05

Identifier Type: -

Identifier Source: org_study_id

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