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NCT Number: NCT04794062

Myocardial Injury and Quality of Life After COVID-19

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.

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Key information

Conditions

COVID-19 Cardiomyopathies Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Myocardial Injury Myocarditis Myocarditis Post Infection Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Voronezh Region Clinical, Consultative and Diagnostic Center

Voronezh, Voronezh Oblast, 394018, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.

    Time frame: Up to 12 months

    Decrease of the left ventricle ejection fraction below 57% in men and women or decrease of the right ventricle ejection fraction below 52% in men and 51% in women.

  2. Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.

    Time frame: Up to 12 months

    Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.

  3. Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.

    Time frame: Up to 12 months

    Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.

Sponsors and collaborators

Lead sponsor

Voronezh Regional Clinical Consultative and Diagnostic Center

Network

Collaborators

  • Charles University, Czech Republic
  • Voronezh State Medical University named after N.N. Burdenko

Registry information

Official study title

Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2021
Registry last updated
Nov 19, 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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