Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
Key facts
- Where
- Chambray Les Tours és Tours Cedex 9, FranciaországSee the 2 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Regional Universitaire De ToursChambray Les Tours, FranciaországNo longer taking part
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Regional Universitaire De Tours
- Trial code
- EU 2024-514543-28-00
- Record updated
- 2024. szeptember 16.
- Original description
Évaluer l’impact de la vaccination antigrippale à 1 mois sur la réponse inflammatoire systémique (hsCRP) chez les patients atteints d’une maladie coronarienne stable.Read full original descriptionShow less
Évaluer l’impact de la vaccination antigrippale à 1 mois sur la réponse inflammatoire systémique (hsCRP) chez les patients atteints d’une maladie coronarienne stable.
Inclusion: Subjects aged ≥ 60 years; With documented stable coronary artery disease; Subjects who, in the opinion of the investigator, can comply with protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff); Signature of free, written and informed consent by the patient; Subjects aged ≥ 60 years. - With documented stable coronary artery disease. - Subjects who, in the opinion of the investigator, can comply with protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff). - Signature of free, written and informed consent by the patient. - Affiliation to a French social security system.
Exclusion: Participant has received the influenza vaccine within <6 months or another vaccine; Cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period; Patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring; History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination; Acute infection within <3 months or acute worsening of chronic diseases; Severe neurocognitive disorders (inability to give informed consent); Pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) ; Patient under guardianship, curatorship or safeguard of justice.