Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2020-09-11
2022-12-31
Brief Summary
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Detailed Description
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The de-identified participant data will be abstracted from the medical chart prospectively on the day of discharge or retrospectively (on the day of the first outpatient visit) and entered into an electronic database. The information will be stored in a database, and used at a later time for research studies.
Patients will be followed up for at least 12 months. Data on standard clinical assessment, echocardiography, laboratory results, assessment of the current therapy, specific cardiovascular assessment (depending on the cardiovascular disease), and outcomes will be collected, as well as additional blood samples for biomarkers substudy and central core laboratory imaging assessment (when applicable) at 3, 6 and 12 months. The investigators will contact patients by telephone to obtain information about outcomes in case of inability to visit in person.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Myocarditis
Proven or suspected myocarditis
No interventions assigned to this group
Heart failure
Heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19
No interventions assigned to this group
ACS
Combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention
No interventions assigned to this group
Pulmonary embolism
Proven pulmonary embolism
No interventions assigned to this group
Arrhythmias
Hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Hospitalization with confirmed or suspected COVID-19 (ICD-10 codes U07.1 or U07.2)
3. Involvement of the cardiovascular system or baseline severe cardiovascular diseases defined as at least of the following:
* proven or suspected myocarditis;
* heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19;
* combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention;
* proven pulmonary embolism;
* hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER
Responsible Party
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Locations
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Almazov National Medical Research Centre
Saint Petersburg, , Russia
Countries
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Facility Contacts
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Other Identifiers
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0509-20-2020
Identifier Type: -
Identifier Source: org_study_id
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