COVID-19, Myocardial Injury, Myocarditis Post Infection
Conditions
Keywords
COVID-9, myocardial injury, myocarditis
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.
Interventions
None listed
Sponsors
Voronezh State Medical University named after N.N. Burdenko
Charles University, Czech Republic
Voronezh Regional Clinical Consultative and Diagnostic Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. | 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. |
| Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion. | 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. |
| Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium. | Up to 12 months | Presence of early and late gadolinium enhancement of myocardium on cardiac MRI. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Recovered From COVID-19 Patients who recovered from COVID-19 and had a history of a positive polymerase chain reaction (PCR) test for SARS-CoV-2 (based on the data of the regional medical database). | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Patients Recovered From COVID-19 |
|---|---|
| Age, Continuous | 57.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 106 Participants |
| Region of Enrollment Russia | 106 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.
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.
Time frame: Up to 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Recovered From COVID-19 | Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. | Decreased function of left ventricle | 19 Participants |
| Patients Recovered From COVID-19 | Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. | Decreased function of right ventricle | 39 Participants |
| Patients Recovered From COVID-19 | Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. | No decrease in left or right ventricle function | 48 Participants |
Primary
Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.
Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.
Time frame: Up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Recovered From COVID-19 | Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium. | Presence of early and late gadolinium enhancement of myocardium. | 28 Participants |
| Patients Recovered From COVID-19 | Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium. | No early and late gadolinium enhancement of myocardium. | 78 Participants |
Primary
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.
Time frame: Up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Recovered From COVID-19 | Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion. | Pericardial effusion | 27 Participants |
| Patients Recovered From COVID-19 | Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion. | No pericardial effusion | 79 Participants |
Post Hoc
Evaluation of Quality of Life of the Patients Recovered From the COVID-19 by the Duke Activity Status Index.
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.
Time frame: At the time of enrollment, but analysis of quality of life criteria was additionally decided to be performed as a separate sub-study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Recovered From COVID-19 | Evaluation of Quality of Life of the Patients Recovered From the COVID-19 by the Duke Activity Status Index. | 31.8 units on a scale | Standard Deviation 12.3 |