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Myocardial Injury and Quality of Life After COVID-19

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ClinicalTrials.gov Identifier: NCT04794062
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
Voronezh State Medical University named after N.N. Burdenko
Charles University, Czech Republic
Information provided by (Responsible Party):
Roman Khokhlov, Voronezh Regional Clinical Consultative and Diagnostic Center

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.

Condition or disease
COVID-19 Myocardial Injury Myocarditis Post Infection

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of patients (%) recovered from COVID-19 with signs of myocardial injury on cardiac magnetic resonance imaging. [ Time Frame: Up to 12 months ]

    Myocardial injury on magnetic resonance imaging of the heart with contrast enhancement is determined by the presence of any of the following:

    1. Signal enhancement of myocardial tissue on T2-weighted images (above 2 times compared to the signal intensity of skeletal muscles);
    2. Myocardial tissue signal enhancement on T1-weighted images during the early phase of gadolinium contrast (signal intensity above 4 times compared to the signal intensity of skeletal muscles or absolute enhancement of the signal above 45%);
    3. Presence of at least one focus of the signal enhancement of the myocardial tissue during the late phase of gadolinium contrast;
    4. Presence of pericardial effusion with the thickening of the pericardial layers more than 3mm;
    5. Presence of the left and/or right ventricle wall motion abnormalities;
    6. 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 myocardial injury on echocardiography. [ Time Frame: Up to 12 months ]

    Myocardial injury on echocardiography is determined by the presence of any of the following:

    1. Presence of regional wall motion abnormalities of the left ventricle in a form of akinesia, hypokinesia, dyskinesia, or hyperkinesia of the corresponding segments of the left ventricle;
    2. Decrease of the left ventricle ejection fraction below 52% in women and 54% in men;
    3. Presence of right ventricular dysfunction in a form of end-diastolic diameter increase above 42 mm at the base and 35 mm at the middle level, or increase of the right ventricle longitudinal size above 86 mm, or decrease of tricuspid annular plane systolic excursion below 17 mm;
    4. 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. Evaluation of quality of life of the patients recovered from the COVID-19 by the means of EQ-5D questionnaire. [ Time Frame: Up to 12 months ]
    The quality of life using the EQ-5D questionnaire is analyzed according to this methodology as a 3-point assessment of quality of life in 5 components (dimensions): D1 - mobility and ability to move, D2 - taking care of oneself, D3 - activities of daily life, D4 - pain and/or discomfort, D5 - anxiety/depression with the definition of the participant's individual health profile in a form of "D1, D2, D3, D4, D5".

  4. Evaluation of quality of life of the patients recovered from the COVID-19 by the means of EQ-5D visual analogue scale. [ Time Frame: Up to 12 months ]
    Assessment of quality of life with the help of visual analogous scale (EQ-VAS) in points from 0 to 100, where 100 is the best possible health condition in the patient's view.

  5. Evaluation of quality of life of the patients recovered from the COVID-19 by the Duke Activity Status Index. [ Time Frame: Up to 12 months ]
    The Duke Activity Status Index is an assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Positive responses are summed up to get a total score, which ranges from 0 to 58.2. Higher scores would indicate a higher functional capacity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794062


Contacts
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Contact: Leonid Khokhlov, MD +(420) 774564302 leonkhokhlov@gmail.com
Contact: Roman Khokhlov, MD +(7) 9103428865 khokhlovroman@gmail.com

Locations
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Russian Federation
Voronezh Region Clinical, Consultative and Diagnostic Center Recruiting
Voronezh, Voronezh Region, Russian Federation, 394018
Contact: Roman Khokhlov, MD    +(7) 9103428865    khokhlovroman@gmail.com   
Sponsors and Collaborators
Voronezh Regional Clinical Consultative and Diagnostic Center
Voronezh State Medical University named after N.N. Burdenko
Charles University, Czech Republic
Investigators
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Principal Investigator: Roman Khokhlov, MD Voronezh Regional Clinical Consultative and Diagnostic Center
  Study Documents (Full-Text)

Documents provided by Roman Khokhlov, Voronezh Regional Clinical Consultative and Diagnostic Center:
Informed Consent Form  [PDF] September 16, 2020

Additional Information:
Publications:
Medical rehabilitation during the novel coronavirus 19 disease (COVID-19). Physical and rehabilitation medicine, medical rehabilitation. 2020;2(2):140-189. DOI: https://doi.org/10.36425/rehab34231
Temporary methodical recommendation "Prophylaxis, diagnosis, and treatment of the novel coronavirus 19 (COVID-19)", 9th Edition released on 10/26/2020
Comparative investigation of informative yield of non-invasive diagnostics methods of inflammatory diseases of myocardium. Russian cardiology journal 2018, (154): 53-59. http://dx.doi.org/10.15829/1560-4071-2018-2-53-59
Guidelines for the management of myocarditis. Eurasian cardiology journal 2015;3:5-17
Life quality of the Russian population by the data from ESSE-RF study. Cardiovascular Therapy and Prevention, 2016; 15(5): 84-90 http://dx.doi.org/10.15829/1728-8800-2016-5-84-90
Health-related quality of life population indicators using EQ-5D questionnaire. Zdravookhranenie Rossiiskoi Federatsii (Health Care of the Russian Federation, Russian journal). 2018; 62(6): 295-303. (In Russ.) DOI: http://dx.doi.org/10.18821/0044-197Х-2018-62-6-295-303
Alexandrova E.A., Herry J. Populational indicators of quality of life related to the health according to EQ-5D questionnaire. Healthcare of the Russian Federation. 2018; 62(6): 295-303. DOI: http://dx.doi.org/10.18821/0044-197Х-2018-62-6-295-303.

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Responsible Party: Roman Khokhlov, MD, Professor, Doctor of Sciences (Dr.Sc.), Voronezh Regional Clinical Consultative and Diagnostic Center
ClinicalTrials.gov Identifier: NCT04794062    
Other Study ID Numbers: 08092020
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roman Khokhlov, Voronezh Regional Clinical Consultative and Diagnostic Center:
COVID-9
myocardial injury
myocarditis
Additional relevant MeSH terms:
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Myocarditis
Wounds and Injuries
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases