Russian Cardiovascular Registry of COVID-19

Study Overview
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Brief Summary
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This is a Russian multicenter observational study aimed to assess the mid-term and long-term prognosis in patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.

Detailed Description
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This open multi-center observational study (registry) is designed to enroll consecutive eligible patients hospitalized with and recovered from COVID-19 (ICD-10 codes U07.1 or U07.2) with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases. Data collection is ongoing for the duration of the pandemic. This study aims to assess the mid-term and long-term prognosis in this patient population. Analysis of this information may help to better predict the prognosis for patients and socio-economic burden of the coincidence of COVID-19 and cardiovascular diseases and to better inform about the optimal surveillance programs in recovered patients. 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.

Official Title
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An Open Multicenter Observational Study (Registry) of Patients Recovered From Novel Coronavirus Infection (COVID-19) With Involvement of the Cardiovascular System or With Baseline Severe Cardiovascular Diseases

Conditions
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Covid19, Acute Cardiovascular Disease, Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years of age Hospitalization with confirmed or suspected COVID-19 (ICD-10 codes U07.1 or U07.2) 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: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocarditis<br>Proven or suspected myocarditis | |
| Heart failure<br>Heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19 | |
| ACS<br>Combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention | |
| Pulmonary embolism<br>Proven pulmonary embolism | |
| Arrhythmias<br>Hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Number of patients died during the follow up | 12 months | 
| Hospitalization for cardiovascular reasons | Number of patients hospitalized for cardiovascular reasons during the follow up | 12 months | 
| Hospitalization for any reason | Number of patients hospitalized for any reason during the follow up | 12 months | 
| Time to death | Number of days to death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical support or heart transplant | Proportion of subjects requiring mechanical support or heart transplant during the follow up | 12 months | 
| ICD or CRT | Proportion of subjects requiring ICD or CRT | 12 months | 
| Quality of life | Changes in quality of life assessed by The Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores are scaled from 0 to 100 and higher scores represent better health status and outcome) | 12 months | 
| Cardiac pacing or catheter ablation | Proportion of subjects requiring cardiac pacing or cathether ablation | 12 months | 
| Syncope or presyncope | Frequency of syncope or presyncope | 12 months | 
| Arrythmias | Frequency of arrythmias | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Covid19, Cardiovascular disease