Official Title
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
Brief 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.

Unknown status
COVID19
Acute Cardiovascular Disease
Cardiovascular Diseases
Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years of age

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:

- None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

Almazov National Medical Research Centre
Saint Petersburg, Russian Federation

Investigator: Alexandra Konradi, MD, PhD
Contact: 007(812)7023749
ahleague@mail.ru

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
NCT Number
Keywords
SARS-CoV-2
COVID19
Cardiovascular disease
MeSH Terms
COVID-19
Cardiovascular Diseases