Cardiovascular Events for a Long Time End of COVID 19 Infection

NCT05729152 | Unknown

• 1 other identifier: 5031
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Myocardial Disease

Keywords

acute myocardial injury; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  The 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.

  6 months

Secondary Outcomes (1)

• Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection

  3 months

Interventions

Sample blood OTHER

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

Also known as: Objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study plans to enroll 240 partecipants hospitalized during the acute phase of COVID-19 infection.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Istituto Auxologico Italiano IRCSS Ospedale San Luca

Milan, 20149, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Cardiomyopathies; COVID-19

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 15, 2023
• Study Start: September 6, 2022
• Primary Completion: December 7, 2022
• Study Completion: May 26, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

IT (2)