Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients infected with HIV

Age under 18

Under court supervision, guardianship, or curatorship

Patients with a history of infective endocarditis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Take 1 ml of blood

    Biological/Vaccine

    Take 1 ml of blood

  • DNA sequencing

    Biological/Vaccine

    DNA sequencing

  • Valve collection (healthcare waste)

    Procedure/Surgery

    Valve collection (healthcare waste)

  • Collection of serious post-operative complications

    Other intervention

    Collection of serious post-operative complications

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with an indication for cardiac surgeryExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Occurrence of a serious postoperative complication

Number of ischemic or hemorrhagic strokes; re-intervention, infective endocarditis, aortic bioprosthesis degeneration, aortic bioprosthesis thrombosis, mortality, surgical site infection requiring repeat surgery

Time frame
48 months

Secondary outcomes

1

Determine the microbiological composition of saliva

Determine the components of the salivary microbiota

Time frame
48 months
2

Determine the components of the microbiota of periodontal plaque

Determine the components of the microbiota of periodontal plaque

Time frame
48 months
3

Oral health assessment

Oral health assessment using the oral health assessment questionnaire called "Oral Study" which asks questions about the use of a toothbrush, interdental brushes, the frequency of visits to the dentist, and the use of mouthwash.

Time frame
48 months
4

Evaluation of hygiene and dietary habits

Assessment of dietary habits using a questionnaire on eating habits and the frequency of consumption of certain foods (bread, rusks, rice, pasta, vegetables, fruits, dairy products, fish, meat) with multiple choices between: Several times a day - Once a day - Several times a week - Once or twice a month - Never

Time frame
48 months

Other outcomes

Sponsors and contacts

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