Investigating the role of bacteria in calcific aortic valve disease
Calcific Aortic Valve Disease: a Multidisciplinary Approach to Investigate the Role of Bacteria as Trigger of a Chronic Inflammation in the Pathogenesis of Calcification
This study is looking to see if bacteria play a role in causing calcific aortic valve disease and how it might affect inflammation in patients with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT05806411 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the contribution of bacteria to calcific aortic valve disease (CAVD) and its associated chronic inflammation. Researchers will analyze valve samples from patients with varying degrees of calcification to assess the presence of bacteria and its correlation with calcification markers. The study will involve in vitro assessments of primary cells obtained from valve cusps to understand how bacterial infection may influence valve degeneration. The findings could provide insights into the mechanisms underlying CAVD and potential therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with calcific aortic sclerosis at stages III and IV.
Not a fit: Patients who do not have calcific aortic sclerosis or are unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing or treating calcific aortic valve disease.
How similar studies have performed: There is currently no literature indicating prior success with similar approaches, making this study novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\>18 years. * Calcific aortic sclerosis (stage III and IV) Exclusion Criteria: - Inability to comply with the requirements of the protocol.
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San MAtteo — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Elena Seminari, MD — Fondazione IRCCS Policlinico San MAtteo
- Study coordinator: Elena Seminari, MD
- Email: e.seminari@smatteo.pv.it
- Phone: +39 0382503811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.