An observational study in Covid19, Acute Cardiovascular Disease and Cardiovascular Diseases, sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 900 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population are the patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.
Involvement of the cardiovascular system or baseline severe cardiovascular diseases defined as at least of the following:
Exclusion Criteria:
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
Death
Number of patients died during the follow up
Time frame: 12 months
Hospitalization for cardiovascular reasons
Number of patients hospitalized for cardiovascular reasons during the follow up
Time frame: 12 months
Hospitalization for any reason
Number of patients hospitalized for any reason during the follow up
Time frame: 12 months
Time to death
Number of days to death
Time frame: 12 months
Mechanical support or heart transplant
Proportion of subjects requiring mechanical support or heart transplant during the follow up
Time frame: 12 months
ICD or CRT
Proportion of subjects requiring ICD or CRT
Time frame: 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)
Time frame: 12 months
Cardiac pacing or catheter ablation
Proportion of subjects requiring cardiac pacing or cathether ablation
Time frame: 12 months
Syncope or presyncope
Frequency of syncope or presyncope
Time frame: 12 months
Arrythmias
Frequency of arrythmias
Time frame: 12 months
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health