Characterization and Prognostic Role of Myocardial Injury in Patients With COVID-19. The CardioCOVID Gemelli Study.

NCT05392088 | Recruiting

• 1 other identifier: 4923
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The present retrospective and prospective observational study aims at evaluate the clinical predictors of myocardial injury in patients hospitalized for COVID-19 infection since the introduction of vaccines that could allow the development of predictive models as well as help clinicians in the early assessment of the risk of myocardial injury and the prevention of the associated unfavourable outcomes. Furthermore, this study will characterize the cardiovascular outcomes in the post-acute COVID-19 phase, and it will evaluate for the first time the long-term clinical outcomes of patients who experienced myocardial injury, possibly paving the way for the implementation of specific therapies aiming to reduce the cardiovascular risk and the long- term sequelae of COVID-19.

Conditions

Myocardial Injury; COVID-19

Keywords

Myocardial Injury; COVID-19

Outcome Measures

Primary Outcomes (1)

• To identify the clinical predictors of myocardial injury

  Th occurence of clinical predictors of myocardial injury during the index hospitalization (defined as at least one value of hs-cTnI \>99th percentile upper reference limit) will be evaluated using univariable and multivariable logistic regression models. Results will be expressed as odds ratio (OR) with 95% confidence interval (CI).

  Up to 30 days

Secondary Outcomes (2)

• To assess the correlation between myocardial injury and in-hospital complications

  Up to 30 days

• To assess if myocardial injury can predict MACE at 1-year follow-up

  1 year

Study Arms (2)

Miocardial injury

Patients hospitalized at Policlinico Universitario A. Gemelli IRCSS since March 1, 2021, with a diagnosis of SARS-CoV-2 infection (≥1 positive nasopharyngeal swab) and at least one value of high-sensitivity cardiac troponin I (hs-cTnI) \>99th percentile upper reference limit measured during the index hospitalization.

Other: DATA EXTRACTION; Other: FOLLOW-UP

No Miocardial injury

Patients hospitalized at Policlinico Universitario A. Gemelli IRCSS since March 1, 2021, with a diagnosis of SARS-CoV-2 infection (≥1 positive nasopharyngeal swab) and value of high-sensitivity cardiac troponin I (hs-cTnI) \<99th percentile upper reference limit.

Other: DATA EXTRACTION; Other: FOLLOW-UP

Interventions

DATA EXTRACTION OTHER

For all patients enrolled Data Mart COVID-19 developed within Generator Real World will be used to automatically extract both structured and unstructured data from hospital databases of patients infected from SARS-CoV-2.The specific data that which will be exploited are: * Demographics data; * Patient comorbidities, vital signs and symptoms at the time of admission; * Laboratory analysis; * In-hospital complications (e.g.: need for non-invasive or invasive ventilation, access to intensive care unit, length of hospitalization, use of glucocorticoids or antibiotics, death); * Blood gas exchange information; * Radiological reports; * Medications at the time of admission, during hospitalization and at the time of discharge; * Vaccination status.

Miocardial injury; No Miocardial injury

FOLLOW-UP OTHER

All patients will undergo a clinical follow-up by telephonic interview and/or clinical visit at 12 months from hospital discharge, during which the incidence of MACE, dysrhythmias, inflammatory heart disease and/or thrombotic disorders (both as incidence of the composite and as incidence of each individual components) in the past months will be investigated.

Miocardial injury; No Miocardial injury

Eligibility Criteria

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

Study Population

All consecutive patients hospitalized at Policlinico Universitario A. Gemelli IRCSS since March 1, 2021, with a diagnosis of SARS-CoV-2 infection (≥1 positive nasopharyngeal swab) and at least one value of high-sensitivity cardiac troponin I (hs-cTnI) measured during the index hospitalization will be enrolled.

You may qualify if:

• Age ≥18 years;
• Overt COVID-19 infection (molecular nasopharyngeal swab positive for SARS-CoV-2 ≥1);
• Patient with at least a high sensitivity Troponin I measured during hospitalization course.
• Available data on vaccination.
• Verbal informed consent

You may not qualify if:

• Age \<18 years;
• Patient in whom at least one high sensitivity Troponin I value measured during the course of hospitalization is not available.
• No data available on vaccination status.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Rocco A Montone, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco A Montone, MD, PhD

CONTACT

+39-0630154187; roccoantonio.montone@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IRCCS Researcher

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 26, 2022
• Study Start: May 6, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)