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Cardiovascular Events for a Long Time End of COVID 19 Infection

LONGCOVID WP3 Cardiovascular Events for a Long Time End of COVID 19 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05729152
Acronym
LONGCOVIDWP3
Enrollment
240
Registered
2023-02-15
Start date
2022-09-06
Completion date
2023-05-26
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Disease

Keywords

acute myocardial injury, COVID-19

Brief summary

In the follow-up of partecipants with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies on the acute phase of Covid-19 infection have demonstrated a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase. The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Detailed description

The study is a continuation of the CARDICoVRISK registry project (Cardiovascular risk and effects ancillary effects of cardiology drug therapy during n-CoV-19 infection), which collected data on alterations cardiovascular changes during the acute phase and shortly after the acute phase. The design of the current study is observational cross-sectional comparison with historical data. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Enrollment of patients will be carried out in three separate centers. Enrolled patients will undergo a baseline assessment by history, objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

Interventions

Partecipants will undergo a baseline assessment by history, objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

* partecipants with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab at least 12 months prior to enrollment; * adult partecipants between the ages of 18 and 90 years old; * signature of informed consent;

Exclusion criteria

* partecipants with poor echocardiographic acoustic window impairing the performance of the examination * partecipants with atrial fibrillation * partecipants with ischemic or nonischemic heart disease with known decreased systolic function of the left ventricle left

Design outcomes

Primary

MeasureTime frameDescription
Identify long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage in approximately 240 subjects who have been affected by COVID 196 monthsThe main purpose of this study is to identify long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage. The anatomical and functional substrates of cardiovascular manifestations will be analyzed by basic and advanced echocardiographic technologies and, when appropriate, by MRI cardiac magnetic resonance imaging. Acute myocardial damage will be estimated by observation of troponin values already collected during acute infection as part of the CARDICoVRISK registry. Distant myocardial damage will be assessed by the assessments provided in the baseline visit.

Secondary

MeasureTime frameDescription
Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection3 monthsA secondary objective is to evaluate functional and anatomical abnormalities as pathophysiologic substrates of dysfunction diastolic and the onset of heart failure at preserved ejection fraction, furthermore in partecipants who, during the baseline visit, will show cardiac alterations the execution of a cardiac magnetic resonance examination will be evaluated.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026