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
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|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- Diagnostic Test: ECG
12 lead electrocardiogram
- 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
- 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
- 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)
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
|Contact: Matteo Bertini, MD, PhDemail@example.com|
|Principal Investigator:||Matteo Bertini, MD, PhD||s.anna university hospital|