Cardiovascular and Psychological Consequences of COVID-19

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

Study Overview

• Status: Completed
• Conditions: Post-COVID Conditions

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 Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • ICS Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who will refer to the disease clinics 2-3 months after discharge from the COVID-19 areas of ICS Maugeri.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of patients with cardiovascular or psychological sequelae	3 months

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

General Publications

• Vigore M, Steccanella A, Maffoni M, Torlaschi V, Gorini A, La Rovere MT, Maestri R, Bussotti M, Masnaghetti S, Fanfulla F, Pierobon A. Patients' Clinical and Psychological Status in Different COVID-19 Waves in Italy: A Quanti-Qualitative Study. Healthcare (Basel). 2023 Sep 6;11(18):2477. doi: 10.3390/healthcare11182477.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CE 2450

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No