Trial Outcomes & Findings for Myocardial Injury and Quality of Life After COVID-19 (NCT NCT04794062)
NCT ID: NCT04794062
Last Updated: 2024-11-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myocardial Injury and Quality of Life After COVID-19
Baseline characteristics by cohort
| Measure |
Patients Recovered From COVID-19
n=106 Participants
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).
|
|---|---|
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Age, Continuous
|
57.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Russia
|
106 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsDecrease 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.
Outcome measures
| Measure |
Patients Recovered From COVID-19
n=106 Participants
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).
The main inclusion criteria were:
1\) age above 18 years and a confirmation of COVID-19 according to regional PCR database (quantitative determination of the titer of IgG/M antibodies in some cases); 2) negative result of a control PCR at the time of inclusion to the study; 3) stable medical condition of a participant, which allows examination on an outpatient basis; 4) signed informed consent.
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|---|---|
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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
|
|
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
|
|
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 outcome
Timeframe: Up to 12 monthsPresence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.
Outcome measures
| Measure |
Patients Recovered From COVID-19
n=106 Participants
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).
The main inclusion criteria were:
1\) age above 18 years and a confirmation of COVID-19 according to regional PCR database (quantitative determination of the titer of IgG/M antibodies in some cases); 2) negative result of a control PCR at the time of inclusion to the study; 3) stable medical condition of a participant, which allows examination on an outpatient basis; 4) signed informed consent.
|
|---|---|
|
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
Pericardial effusion
|
27 Participants
|
|
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
No pericardial effusion
|
79 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPresence of early and late gadolinium enhancement of myocardium on cardiac MRI.
Outcome measures
| Measure |
Patients Recovered From COVID-19
n=106 Participants
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).
The main inclusion criteria were:
1\) age above 18 years and a confirmation of COVID-19 according to regional PCR database (quantitative determination of the titer of IgG/M antibodies in some cases); 2) negative result of a control PCR at the time of inclusion to the study; 3) stable medical condition of a participant, which allows examination on an outpatient basis; 4) signed informed consent.
|
|---|---|
|
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
|
|
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
|
POST_HOC outcome
Timeframe: At the time of enrollment, but analysis of quality of life criteria was additionally decided to be performed as a separate sub-study.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.
Outcome measures
| Measure |
Patients Recovered From COVID-19
n=100 Participants
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).
The main inclusion criteria were:
1\) age above 18 years and a confirmation of COVID-19 according to regional PCR database (quantitative determination of the titer of IgG/M antibodies in some cases); 2) negative result of a control PCR at the time of inclusion to the study; 3) stable medical condition of a participant, which allows examination on an outpatient basis; 4) signed informed consent.
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|---|---|
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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
|
Adverse Events
Patients Recovered From COVID-19
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place