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
|Condition or disease|
|COVID-19 Myocardial Injury Myocarditis Post Infection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- 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:
- Signal enhancement of myocardial tissue on T2-weighted images (above 2 times compared to the signal intensity of skeletal muscles);
- 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%);
- Presence of at least one focus of the signal enhancement of the myocardial tissue during the late phase of gadolinium contrast;
- Presence of pericardial effusion with the thickening of the pericardial layers more than 3mm;
- Presence of the left and/or right ventricle wall motion abnormalities;
- 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.
- 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:
- 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;
- Decrease of the left ventricle ejection fraction below 52% in women and 54% in men;
- 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;
- Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.
- 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".
- 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.
- 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.
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
|Contact: Leonid Khokhlov, MD||+(420) firstname.lastname@example.org|
|Contact: Roman Khokhlov, MD||+(7) email@example.com|
|Voronezh Region Clinical, Consultative and Diagnostic Center||Recruiting|
|Voronezh, Voronezh Region, Russian Federation, 394018|
|Contact: Roman Khokhlov, MD +(7) 9103428865 firstname.lastname@example.org|
|Principal Investigator:||Roman Khokhlov, MD||Voronezh Regional Clinical Consultative and Diagnostic Center|