CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 1,500 target
Drug / intervention
DATA EXTRACTION +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05392088
NCT05392088N/AUnknown

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted May 26, 2022·Updated Feb 26, 2024

In Brief

An observational study evaluating DATA EXTRACTION and FOLLOW-UP for Myocardial Injury and COVID-19. Targeting 1,500 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/AUnknownOverdue
2023202420252026
First PostedMay 26, 2022
Enrollment StartMay 6, 2022
Primary CompletionAug 1, 2024
TodayJul 1, 2026
Enrollment to primary: 2.2 yearsPosted 4.1 years ago

Interventions

DATA EXTRACTIONother

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.

FOLLOW-UPother

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.