Cardiovascular and Psychological Consequences of COVID-19

Completed

• Conditions: Post-COVID Conditions

• Registration Number: NCT05758649
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.

Detailed Description

A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.

Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.

The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.

A second follow-up visit will be performed at 12 months in the form of structured interview,

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease

Exclusion Criteria

• Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
• Non-Italian education, illiteracy, or return to illiteracy.
• Severe visual-perceptual deficits.
• Low motivation/interest or refusal to undergo the assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of patients with cardiovascular or psychological sequelae	3 months

Trial Locations

Locations (1)

ICS Maugeri; 🇮🇹 Pavia, Italy