Russian Cardiovascular Registry of COVID-19

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724707
• Other study ID #: 0509-20-2020
• Status: Recruiting
• Start date: September 11, 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cardiovascular Disease
• Cardiovascular Diseases
• Covid19

Locations

Country	Name	City	State
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Number of patients died during the follow up	12 months
Primary	Hospitalization for cardiovascular reasons	Number of patients hospitalized for cardiovascular reasons during the follow up	12 months
Primary	Hospitalization for any reason	Number of patients hospitalized for any reason during the follow up	12 months
Primary	Time to death	Number of days to death	12 months
Secondary	Mechanical support or heart transplant	Proportion of subjects requiring mechanical support or heart transplant during the follow up	12 months
Secondary	ICD or CRT	Proportion of subjects requiring ICD or CRT	12 months
Secondary	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
Secondary	Cardiac pacing or catheter ablation	Proportion of subjects requiring cardiac pacing or cathether ablation	12 months
Secondary	Syncope or presyncope	Frequency of syncope or presyncope	12 months
Secondary	Arrythmias	Frequency of arrythmias	12 months