Clinical trial NCT05729152: Cardiovascular Events for a Long Time End of COVID 19 Infection
Official title: LONGCOVID WP3 "Cardiovascular Events for a Long Time End of COVID 19 Infection "
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Disease
Keywords: acute myocardial injury
COVID-19
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study plans to enroll 240 partecipants hospitalized during the acute phase of COVID-19 infection.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 19
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection
timeFrame: 3 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano IRCSS Ospedale San Luca
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: