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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Covid19; Acute Cardiovascular Disease

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197341
    • Recruiting
    • Almazov National Medical Research Centre
    • Contact: Alexandra Konradi, MD, PhD; Phone Number: 005103 007(812)7023749; Email: ahleague@mail.ru
    • Contact: Svetlana Villevalde, MD, PhD; Email: villevaldes@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population are the patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Myocarditis; Proven or suspected myocarditis
Heart failure; Heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19
ACS; Combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention
Pulmonary embolism; Proven pulmonary embolism
Arrhythmias; 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?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Cardiovascular disease; Covid19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Cardiovascular Diseases
• Other Study ID Numbers: 0509-20-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No