SARS-CoV InfectionELCOVIDNCT04367129
Electrocardiogram Analysis in COVID-19 Patients
An observational study of SARS-CoV Infection, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- ECG
- How many people
- 1,014 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with SARS-CoV-2 infection
Who may be able to join
- 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
Who cannot join
- SARS-CoV-2 infection not confirmed by pharyngeal swab or clinical-radiographic criteria
- absence of ECG tracing performed at the time of hospitalization
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Arcispedale S. Anna
Ferrara, 44124
Matteo Bertini, MD, PhD, 3474010904, doc.matber@gmail.com
Michele Malagù, MD, 00390532239891, mlgmhl1@unife.it
About this study
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.
Read the 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
- Conditions
- SARS-CoV Infection
- Being tested
- ECG
- Keywords
- ECG, SARS-CoV-2 Infection, Mortality, Invasive mechanical ventilation
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
12 lead electrocardiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start14 Apr 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Bertini, MD, PhD, Principal investigator, s.anna university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367129
- Sponsor's protocol ID
- 385/2020/Oss/AOUFe
- Acronym
- ELCOVID
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided a plan to share individual participant data (IPD)
Publications
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.
PubMed 32219362Guo 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.
PubMed 32219356Chen 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.
PubMed 32007143Zheng 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.
PubMed 32139904Zuin 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.
PubMed 38652232Bertini 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.
PubMed 32944767
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram Analysis in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04367129
- Acronym / sponsor ID
- ELCOVID / 385/2020/Oss/AOUFe
- Conditions
- SARS-CoV Infection
- Keywords
- ECG, SARS-CoV-2 Infection, Mortality, Invasive mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,014 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with SARS-CoV-2 infection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- SARS-CoV-2 infection not confirmed by pharyngeal swab or clinical-radiographic criteria
- absence of ECG tracing performed at the time of hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG12 lead electrocardiogram | Diagnostic test | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 32219362Bonow 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.
- Background: PubMed 32219356Guo 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.
- Background: PubMed 32007143Chen 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.
- Background: PubMed 32139904Zheng 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.
- Derived from this study: PubMed 38652232Zuin 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.
- Derived from this study: PubMed 32944767Bertini 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.
- Individual participant dataSharing planned: Undecided. not yet decided a plan to share individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Bertini, MD, PhD principal investigator
s.anna university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Bertini, MD, PhD (+393474010904, doc.matber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367129, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.