Status:
UNKNOWN
Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Lead Sponsor:
Samara Regional Cardiology Dispensary
Conditions:
Acute Coronary Syndrome
Chronic Heart Failure
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Study Description: Background: Well-known fact that the number of cardiovascular diseases is on the rise during influenza epidemic. It is conceivable that influenza may precipitate plaque rupture, in...
Detailed Description
Detailed Description: Name of investigational treatment: Influenza vaccine ("Ultrix Quadri"™) Planned study period: October - December 2021 ((influenza season) Long-term follow up to 365 days from th...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of ACS with transformation to AMI or unstable angina
- Patients with a diagnosis of CHF Written informed consent.
Exclusion
- • Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
- COVID-19 vaccination during 30 days
- Indication for influenza vaccination for some indication other than myocardial infarction.
- Severe allergy to eggs or previous allergic reaction to influence vaccine.
- Suspicion of febrile illness or acute, ongoing infection.
- Hypersensitivity to the active substances or ingredients of Ultrix Quadri or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
- Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- Inability to provide informed consent.
- Age below 65 years.
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05232292
Start Date
October 6 2021
End Date
May 31 2023
Last Update
February 9 2022
Active Locations (1)
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1
Samara Regional Cardiology Dispansery
Samara, Russia, 443070