Rangueil Hospital
Toulouse, France, 31 000
Location status: Recruiting
Location contact
Audrey TOMASIK
CONTACT
5 61 77 85 97 ext. +33
Bertrand MARCHEIX, MD
CONTACT
561323718 ext. +33
Bertrand MARCHEIX, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07075601
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toulouse, France, 31 000
Location status: Recruiting
Audrey TOMASIK
CONTACT
5 61 77 85 97 ext. +33
Bertrand MARCHEIX, MD
CONTACT
561323718 ext. +33
Bertrand MARCHEIX, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Take 1 ml of blood
DNA sequencing
Valve collection (healthcare waste)
Collection of serious post-operative complications
Time frame: 48 months
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
Determine the components of the salivary microbiota
Time frame: 48 months
Determine the components of the microbiota of periodontal plaque
Time frame: 48 months
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
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
Determining inflammatory molecules in saliva
Time frame: 48 months
Determine the immune cells and molecules found in saliva
Time frame: 48 months
Determine the molecules that make up the fecal microbiota
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Acronym: BIOVALV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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