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

NCT05232292 | Unknown Phase 4

• 1 other identifier: SOKKD003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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, 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

Acute Coronary Syndrome; Chronic Heart Failure

Keywords

acute coronary syndrome; influenza vaccination; prognosis; chronic heart failure

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  сomposite of all-cause death, MI, or stent thrombosis at 12 months

  up to 1 year

Secondary Outcomes (2)

• Secondary endpoint

  up to 1 year

• Secondary endpoint

  1 week after vaccination

Study Arms (2)

Vaccinated

ACTIVE COMPARATOR

vaccinated ACS \& CHF patients over 65 years

Biological: Ultrix Quadri

Not vaccinated

NO INTERVENTION

not vaccinated ACS \& CHF patients over 65 years

Interventions

Ultrix Quadri BIOLOGICAL

vaccination by Ultrix Quadri against flu

Vaccinated

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of ACS with transformation to AMI or unstable angina
• Patients with a diagnosis of CHF Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samara Regional Cardiology Dispensary: lead

Study Sites (1)

Samara Regional Cardiology Dispansery

Samara, 443070, Russia

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Influenza, Human

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Dmitry Duplyakov, Prof

  SOKKD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Duplyakov, Prof

CONTACT

89277297273; duplyakov@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: February 9, 2022
• Study Start: October 6, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)