Russian Cardiovascular Registry of COVID-19

NCT ID: NCT04724707

Last Updated: 2021-01-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-11

Study Completion Date

2022-12-31

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.

Conditions

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Covid19 Acute Cardiovascular Disease Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Almazov National Medical Research Centre

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Alexandra Konradi, MD, PhD

Role: primary

007(812)7023749 ext. 005103

Svetlana Villevalde, MD, PhD

Role: backup

Other Identifiers

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0509-20-2020

Identifier Type: -

Identifier Source: org_study_id

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