Clinical trial NCT04724707: Russian Cardiovascular Registry of COVID-19
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Acute Cardiovascular Disease
Cardiovascular Diseases
Keywords: SARS-CoV-2
Covid19
Cardiovascular disease
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Death
timeFrame: 12 months
measure: Hospitalization for cardiovascular reasons
timeFrame: 12 months
measure: Hospitalization for any reason
timeFrame: 12 months
measure: Time to death
timeFrame: 12 months
Secondary outcomes:
measure: Mechanical support or heart transplant
timeFrame: 12 months
measure: ICD or CRT
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Cardiac pacing or catheter ablation
timeFrame: 12 months
measure: Syncope or presyncope
timeFrame: 12 months
measure: Arrythmias
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
References: