Electrocardiogram Analysis in COVID-19 Patients

NCT04367129 | Unknown

• 1 other identifier: 385/2020/Oss/AOUFe
• Study Type: observational
• Target: 1,014
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV Infection

Keywords

ECG; SARS-CoV-2 Infection; Mortality; Invasive mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection

  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

  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

  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

Interventions

ECG DIAGNOSTIC_TEST

12 lead electrocardiogram

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with SARS-CoV-2 infection

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Arcispedale S. Anna

Ferrara, 44124, Italy

RECRUITING

Related Publications (6)

• Bonow RO, Fonarow GC, O'Gara PT, Yancy CW. Association of Coronavirus Disease 2019 (COVID-19) With Myocardial Injury and Mortality. JAMA Cardiol. 2020 Jul 1;5(7):751-753. doi: 10.1001/jamacardio.2020.1105. No abstract available.

  PMID: 32219362 BACKGROUND

• Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

  PMID: 32219356 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 BACKGROUND

• Zuin M, Ferrari R, Guardigli G, Malagu M, Vitali F, Zucchetti O, D'Aniello E, Di Ienno L, Gibiino F, Cimaglia P, Grosseto D, Corzani A, Galvani M, Ortolani P, Rubboli A, Tortorici G, Casella G, Sassone B, Navazio A, Rossi L, Aschieri D, Mezzanotte R, Manfrini M, Bertini M. A COVID-19 specific multiparametric and ECG-based score for the prediction of in-hospital mortality: ELCOVID score. Intern Emerg Med. 2024 Aug;19(5):1279-1290. doi: 10.1007/s11739-024-03599-3. Epub 2024 Apr 23.

  PMID: 38652232 DERIVED

• Bertini M, Ferrari R, Guardigli G, Malagu M, Vitali F, Zucchetti O, D'Aniello E, Volta CA, Cimaglia P, Piovaccari G, Corzani A, Galvani M, Ortolani P, Rubboli A, Tortorici G, Casella G, Sassone B, Navazio A, Rossi L, Aschieri D, Rapezzi C. Electrocardiographic features of 431 consecutive, critically ill COVID-19 patients: an insight into the mechanisms of cardiac involvement. Europace. 2020 Dec 23;22(12):1848-1854. doi: 10.1093/europace/euaa258.

  PMID: 32944767 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Matteo Bertini, MD, PhD

  s.anna university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Bertini, MD, PhD

CONTACT

+393474010904; doc.matber@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 29, 2020
• Study Start: April 14, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2020-04

Locations

IT (1)