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OpenTrials
Completed

NCT Number: NCT05770336

STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCSS San Raffaele

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Rete cardiologica IRCCS

Registry information

Acronym: LONG-COVID

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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