NCT04724707

Russian Cardiovascular Registry of COVID-19

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Covid19
• Acute Cardiovascular Disease
• Cardiovascular Diseases

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2021-01-26
• Last updated: 2021-01-26

Locations

1 site across 1 country: Russia