Russian Cardiovascular Registry of COVID-19

• Conditions: Cardiovascular Diseases; Covid19; Acute Cardiovascular Disease

• Registration Number: NCT04724707
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

Study Timeline

• Study Start: 2020-09-11
• Status Verified: 2021-01
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	12 months	Number of patients died during the follow up
Hospitalization for any reason	12 months	Number of patients hospitalized for any reason during the follow up
Hospitalization for cardiovascular reasons	12 months	Number of patients hospitalized for cardiovascular reasons during the follow up
Time to death	12 months	Number of days to death

Secondary Outcome Measures

Name	Time	Method
ICD or CRT	12 months	Proportion of subjects requiring ICD or CRT
Arrythmias	12 months	Frequency of arrythmias
Syncope or presyncope	12 months	Frequency of syncope or presyncope
Quality of life	12 months	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)
Mechanical support or heart transplant	12 months	Proportion of subjects requiring mechanical support or heart transplant during the follow up
Cardiac pacing or catheter ablation	12 months	Proportion of subjects requiring cardiac pacing or cathether ablation

Trial Locations

Locations (1)

Almazov National Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation