An observational study in Myocardial Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 240 is close to the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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The study plans to enroll 240 partecipants hospitalized during the acute phase of COVID-19 infection.
Exclusion Criteria:
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
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.
Time frame: 6 months
Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection
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.
Time frame: 3 months
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS