Clinical trial NCT04794062: Myocardial Injury and Quality of Life After COVID-19
Official title: Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Myocardial Injury
Myocarditis Post Infection
Keywords: COVID-9
myocardial injury
myocarditis
Lead sponsor: Voronezh Regional Clinical Consultative and Diagnostic Center
Sponsor class: NETWORK
Collaborators: name: Voronezh State Medical University named after N.N. Burdenko
name: Charles University, Czech Republic
First posted: 2021-03-11
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community population of the Voronezh region in Western Russia, without need of hospitalization, sent to by the primary care physicians.

Brief 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.

Detailed description: The main goal of this observational non-interventional study is the evaluation of prevalence of myocardial injury (heart injury) of the participants recovered from the novel coronavirus infectious disease (COVID-19). Participants with signs of myocarditis (pericarditis) and/or myocardial fibrosis, and with a threat of heart failure development and other outcomes are selected into this study. In this cohort the percentage of participants having myocardial injury based on the level of high-sensitivity troponin, echocardiography (decreased Left Ventricle Ejection Fraction, abnormalities of wall motion, Right Ventricle dysfunction, increased size of heart chambers above referential values, presence of pericardial effusion), cardiac MRI with contrast enhancement (presence of edema on T2-weighted images, presence of early and late gadolinium enhancement phenomenon, local motion abnormalities, increased size of heart chambers above referential values, presence of pericardial effusion). At 6 months of the dynamic follow-up, MRI with contrast enhancement will be repeated in the participants with established myocardial injury at inclusion to assess the percentage of the participants having ongoing myocardial injury.

The secondary goal of the study is evaluation of quality of life of the patients recovered from the novel coronavirus infectious disease (COVID-19) by the means of EQ-5D and/or DASI questionnaire using the descriptive system of 5 components of quality of life related to the wellbeing, and visual analogue scale.

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.

Primary outcomes:
measure: Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.
timeFrame: Up to 12 months
measure: Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
timeFrame: Up to 12 months
measure: Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Voronezh
country: Russian Federation
facility: Voronezh Region Clinical, Consultative and Diagnostic Center
state: Voronezh Region
Study officials:
affiliation: Voronezh Regional Clinical Consultative and Diagnostic Center
name: Roman Khokhlov, MD
role: PRINCIPAL_INVESTIGATOR
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