Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Take 1 ml of blood, DNA sequencing, Valve collection (healthcare waste), Collection of serious post-operative complications.
- Who it may be relevant to
- Registry conditions: Valvulopathy, Cardiac Surgery, Microbiota. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The prevalence of aortic valve disease is increasing, with these valvulopathies present in half of individuals over the age of 65. Oberbach A. et al (1) demonstrated the presence of microbiota in 52% of cases of explanted aortic valves. One current hypothesis is the role of this microbiota in the pathophysiology of these degenerative valve diseases. This microbiota is probably not completely eradicated after resection of the native valve and implantation of a conventional prosthesis; it is even left in place during percutaneous aortic valve implantation, during which the prosthesis is deployed within the native valve. It could therefore also play a role in the occurrence of postoperative complications and the degeneration or thrombosis of a bioprosthesis. Furthermore, recent clinical and epidemiological studies have shown a link between oral infections and cardiovascular diseases. As recommended by the HAS, these patients require multidisciplinary care, involving cardiologists, cardiac surgeons and general practitioners, as well as careful oral and dental care and monitoring provided by specialists in oral pathologies and oral care. The accumulation of bacterial plaque on the surface of the tooth and certain oral bacteria causes the development of periodontal pockets which are characteristic of periodontitis. Bacteria, microbial products and inflammatory mediators produced locally can then enter the bloodstream and affect distant organs such as the cardiovascular system. The recommendations of the European Society of Cardiology are therefore to carry out regular oral and dental consultations to prevent the risk of infection. Therefore, within the Toulouse University Hospital, a care network has been set up for patients with cardiovascular pathologies, in order to improve their access to dental care, screening and management of oral diseases. For the past year, patients hospitalized in the cardiology departments have been seen in consultation in the dental department of the Toulouse University Hospital.
Interventions
- Biological Take 1 ml of blood
Take 1 ml of blood - Biological DNA sequencing
DNA sequencing - Procedure Valve collection (healthcare waste)
Valve collection (healthcare waste) - Other Collection of serious post-operative complications
Collection of serious post-operative complications
Primary outcome measures
- Occurrence of a serious postoperative complication [Time frame: 48 months]
Secondary outcome measures (7)
- Determine the microbiological composition of saliva [Time frame: 48 months]
- Determine the components of the microbiota of periodontal plaque [Time frame: 48 months]
- Oral health assessment [Time frame: 48 months]
- Evaluation of hygiene and dietary habits [Time frame: 48 months]
- Determine the inflammatory composition of saliva [Time frame: 48 months]
- Determine the immune composition of saliva [Time frame: 48 months]
- Determine the microbiological composition of feces [Time frame: 48 months]
Eligibility criteria
Inclusion criteria
- Male or female patient.
- Present an indication for cardiac surgery that requires explantation of the aortic valve.
- Be able to receive information about the study process and understand the study participation information form.
- State their non-opposition to participating in the study.
Exclusion criteria
- Patients infected with HIV
- Age under 18
- Under court supervision, guardianship, or curatorship
- Patients with a history of infective endocarditis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Rangueil Hospital — Toulouse
Identifiers
NCT: NCT07075601 · RC31/25/0020 · 2025-A00422-47