STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

NCT ID: NCT05770336

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-11-30

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.

Conditions

Cardiac Complication; COVID-19 Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patient with previous hospitalization for Covid-19 infection

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rete cardiologica IRCCS

UNKNOWN

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Agricola Eustachio

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eustachio Agricola, MD

Role: STUDY_DIRECTOR

IRCCS San Raffaele

Locations

IRCSS San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

LONG-COVID

Identifier Type: -

Identifier Source: org_study_id