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Clinical Trials/NCT05770336
NCT05770336
Completed
Not Applicable

STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

IRCCS San Raffaele1 site in 1 country120 target enrollmentMarch 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Complication
Sponsor
IRCCS San Raffaele
Enrollment
120
Locations
1
Primary Endpoint
Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Detailed Description

In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown 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. The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram. If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated. Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

Registry
clinicaltrials.gov
Start Date
March 9, 2022
End Date
November 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Agricola Eustachio

PI

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
  • Adult patients between 18 and 90 years of age
  • Signature of informed consent

Exclusion Criteria

  • Patient with poor echocardiographic acoustic window impairing the performance of the examination
  • Patients with atrial fibrillation
  • Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function

Outcomes

Primary Outcomes

Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.

Time Frame: 9 months

The main purpose of this study is to identify the 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

Study Sites (1)

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