2024-514543-28-00Active, not recruitingPhase 2
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- 21 Oct 2024
- Lead sponsor
- Centre Hospitalier Regional Universitaire De Tours
- Diseases
- Coronary artery disease
- EU CT number
- 2024-514543-28-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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) .
Other
- Patient under guardianship, curatorship or safeguard of justice.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Regional Universitaire De Tours | Chambray Les Tours | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours | Tours Cedex 9 | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.