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

NCT05392088 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2024-02-26

No results posted yet for this study

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

Interventions

OTHER

DATA EXTRACTION

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.

OTHER

FOLLOW-UP

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Rocco A Montone, MD, PhD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392088 on ClinicalTrials.gov