Cardiovascular Events for a Long Time End of COVID 19 Infection (LONGCOVIDWP3)

February 17, 2023 updated by: Pedicino Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20149
        • Istituto Auxologico Italiano IRCSS Ospedale San Luca
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection
Time Frame: 3 months
A 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Actual)

December 7, 2022

Study Completion (Anticipated)

May 26, 2023

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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