N/A
N=119
Myocardial Injury and Quality of Life After COVID-19
COVID-19 · Myocardial Injury · Myocarditis Post Infection
Bottom Line
View on ClinicalTrials.gov: NCT04794062 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. — 19; 39; 48 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Voronezh Regional Clinical Consultative and Diagnostic Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. |
19; 39; 48 | — |
| PRIMARY Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion. |
27; 79 | — |
| PRIMARY Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium. |
28; 78 | — |
Summary
In this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by COVID-19. The main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from COVID-19 and follow-up in selected participants with present signs of myocarditis and/or myocardial fibrosis.
Eligibility Criteria
Inclusion Criteria
- Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum;
- Pneumonia development confirmed by chest computed tomography;
- Negative PCR test for SARS-CoV-2 at the time of inclusion into the study;
- Stable patient state allowing outpatient follow-up;
- Signed informed consent.
Exclusion Criteria
- Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion;
- Absence of medical records regarding previous treatment of COVID-19;
- Low compliance and unwillingness to undergo defined examinations;
- Absence of informed consent.
Data sourced from ClinicalTrials.gov (NCT04794062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.