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 (JOCOVID)

January 3, 2023 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Clinical Investigation Center Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During hospital admission (up to 20 days)
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
1st day of admission
Prediction of cardio-vascular events with baseline characteristics
Time Frame: Baseline on first day of admission
Baseline on first day of admission
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
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
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
Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

July 20, 2020

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC1421-20-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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