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OpenTrials
Completed

NCT Number: NCT05758649

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.

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Key information

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. prevalence of patients with cardiovascular or psychological sequelae

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 7, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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