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Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure

NCT05232292 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-02-09

No results posted yet for this study

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, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. A number of studies have shown that the risk of cardiovascular complications (ACS, stroke, CHF decompensation, cardiac arrhythmias) seem to be reduced following influenza vaccination. The Influenza Vaccination After Myocardial Infarction study data published in September 2021 have demonstrated a significant decrease of mortality (by 40%) during 1 year of follow-up in patients with myocardial infarction (MI) who has been vaccinated during the first 72 hours.

Objective: the objective is to find out whether influenza vaccination protects against cardiovascular events and death in ACS \& CHF patients vaccinated during hospitalization Methods: Population: 400 patients aged 65 and older with acute coronary syndrome are randomized 1:1 and followed up via telephone calls and registries (AIS "Mortality").

Patients will be included in the study in cardiology departments № 1, 2, 3, 5, 6 of the State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov" Intervention: Influenza vaccination. Control: group of unvaccinated patients. Planned study period is 1 year.

Conditions

Interventions

BIOLOGICAL

Ultrix Quadri

vaccination by Ultrix Quadri against flu

Sponsors & Collaborators

  • Samara Regional Cardiology Dispensary

    lead OTHER

Principal Investigators

  • Dmitry Duplyakov, Prof · SOKKD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-12-31
Completion
2023-05-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232292 on ClinicalTrials.gov