STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

Completed

• Conditions: Cardiac Complication; COVID-19 Pneumonia

• Registration Number: NCT05770336
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2022-03-09
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-12
• Last Update Submitted: 2023-03-12
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

IRCSS San Raffaele; 🇮🇹 Milan, Italy