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Electrocardiogram Analysis in COVID-19 Patients (ELCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367129
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital of Ferrara

Brief Summary:

Electrocardiographic (ECG) evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection.

The present study involves three different phases of evaluation of the ECG traces of hospitalized patients with SARS-CoV-2 infection.

  • Phase 1: it is proposed to collect and retrospectively analyze the ECGs of hospitalized patients with severe SARS-CoV-2 infection which led to invasive ventilation or patient death as a consequence and, if available, also possible troponin dosage;
  • Phase 2: aims to collect and analyze the ECGs of consecutive hospitalized patients with SARS-CoV-2 infection and evaluate their relationship with the course of the disease, cardiac involvement and prognosis;
  • Phase 3: it is proposed to repeat ECG and to carry out echocardiogram to patients with SARS-CoV-2 infection after 3 months from hospital discharge by simultaneously performing, if deemed clinically indicated, also cardiac magnetic resonance. In this phase, any evolutions of ECG alterations of the acute phase will be described and the relationship with cardiac involvement will be assessed.

Condition or disease Intervention/treatment
SARS-CoV Infection Diagnostic Test: ECG

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrocardiogram Analysis in COVID-19 Patients
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: ECG
    12 lead electrocardiogram


Primary Outcome Measures :
  1. Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection [ Time Frame: 1 month ]
    Describe the ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection

  2. Phase 2: Correlation between ECG signs and needs for invasive mechanical ventilation and/or mortality in the acute phase [ Time Frame: 6 months ]

    To evaluate the correlation between ECG signs and cardiac involvement in the acute phase

    • Assess the correlation between ECG signs and mortality in the acute phase


  3. Phase 3: Correlation between ECG signs and cardiac involvement and mortality in the chronic phase [ Time Frame: 12 months ]

    To evaluate the correlation between acute phase ECG signs and chronic phase cardiac involvement

    • evaluate the appearance, in the short-term follow-up, of signs of cardiac involvement (cardiomyopathies and conduction disorders in particular)




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients with SARS-CoV-2 infection
Criteria

Inclusion Criteria:

  • age >18 years old
  • confirmed SARS-CoV-2 infection (pharyngeal swab positive for viral RNA or clinical diagnosis of COVID-19 based on chest x-ray or high resolution CT)
  • hospitalization in a hospital setting

Exclusion Criteria:

  • SARS-CoV-2 infection not confirmed by pharyngeal swab or clinical-radiographic criteria
  • absence of ECG tracing performed at the time of hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367129


Contacts
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Contact: Matteo Bertini, MD, PhD +393474010904 doc.matber@gmail.com

Locations
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Italy
Arcispedale S. Anna Recruiting
Ferrara, Italy, 44124
Contact: Matteo Bertini, MD, PhD    3474010904    doc.matber@gmail.com   
Contact: Michele Malagù, MD    00390532239891    mlgmhl1@unife.it   
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Matteo Bertini, MD, PhD s.anna university hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT04367129    
Other Study ID Numbers: 385/2020/Oss/AOUFe
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decided a plan to share individual participant data (IPD)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital of Ferrara:
ECG
SARS-CoV-2 Infection
Mortality
Invasive mechanical ventilation
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases