Electrocardiogram Analysis in COVID-19 Patients (ELCOVID)

February 4, 2021 updated by: University Hospital of Ferrara

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the early months of 2020, SARS-CoV-2 virus infection quickly spread around the world to a pandemic. On 2 April 2020, confirmed cases of coronavirus disease 2019 (COVID-19) worldwide exceeded one million and an unprecedented health crisis has occurred in recent history.

SARS-CoV-2 disease can lead to the development of even severe pneumonia with the need for ventilatory support and in some cases fatal outcome.

From the data currently present in the literature, important relationships emerge between infection and cardiovascular diseases. COVID-19 patients with underlying pre-existing heart disease or cardiovascular risk factors have a more severe course of the disease and are more at risk of adverse outcomes and death than individuals with no history of heart disease or risk factors.

During the course of the infection, some patients even without previous heart disease may experience myocardial injury and this leads to a significant increase in in-hospital mortality. Myocardial pain during SARS-CoV-2 infection is associated with cardiac dysfunction and arrhythmias.

To date, there are no data on the role of the electrocardiogram neither in the diagnosis of cardiac involvement nor in predicting the prognosis of patients with SARS-CoV-2 infection.

Whether there are basal electrocardiographic features capable of correlating with the course of the disease and the prognosis is currently unknown. The development of electrocardiographic changes during the course of the disease and their possible prognostic significance has not currently been described.

The present study involves three different phases of evaluation of the electrocardiographic (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.

Phase 1 Retrospective, multicentric, cohort study Phase 2 and 3 prospective, multicentric, cohort study

Phase 1:

• Describe the ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection

Phase 2:

  • To evaluate the correlation between ECG signs and cardiac involvement in the acute phase
  • Assess the correlation between ECG signs and mortality/invasive mechanical ventilation in the acute phase secondary:
  • To evaluate the prevalence of ECG changes in the enrolled population
  • Analyze the prevalence of various cardiovascular risk factors in the enrolled population
  • Examine the impact of ECG changes on the short-term prognosis
  • Explore new possible prognostic risk factors

Phase 3:

  • To evaluate the correlation between acute phase ECG signs and chronic phase cardiac involvement
  • To evaluate the appearance, in the short-term follow-up, of signs of cardiac involvement (cardiomyopathies and conduction disorders in particular)

Data collected:

  • demographic characteristics
  • cardiovascular risk factors
  • comorbidities
  • blood tests including cardiac markers (troponin, BNP) collected in multiple points if available
  • radiographic examinations and echocardiogram (if performed)
  • ECG traces performed at onset, worsening and / or troponin peak
  • length of hospital stay
  • treatments administered
  • complications
  • clinical outcome

Enrolled patients will be followed clinically until the day of discharge as per care practice. A 3-month follow-up is foreseen to evaluate the outcome and repeat the ECG. At the discretion of the clinician who manages the patient, transthoracic echocardiogram and / or cardiac magnetic resonance imaging will also be performed.

A formal calculation of the sample size is not possible due to the total lack of data. Furthermore, since it is an observational project, the calculation of the sample size is not mandatory. However, based on similar studies, it is believed that the minimum samples for the various phases are:

80 patients for Phase 1 study objectives, 800 patients for Phase 2 study objectives and 300 patients for Phase 3 study objectives

Study Type

Observational

Enrollment (Anticipated)

1014

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

  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Arcispedale S. Anna
        • Contact:
        • Contact:

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients with SARS-CoV-2 infection

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month
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
6 months
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)
12 months

Collaborators and Investigators

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

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Matteo Bertini, MD, PhD, s.anna university hospital

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)

April 14, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 385/2020/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not yet decided a plan to share individual participant data (IPD)

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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