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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Almazov National Medical Research Centre | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
Russian Federation,
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 |
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