Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Take 1 ml of blood, DNA sequencing, Valve collection (healthcare waste), Collection of serious post-operative complications.
- Кому может быть актуально
- Состояния в реестре: Valvulopathy, Cardiac Surgery, Microbiota. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Вмешательства
- Биопрепарат Take 1 ml of blood
Take 1 ml of blood - Биопрепарат DNA sequencing
DNA sequencing - Процедура Valve collection (healthcare waste)
Valve collection (healthcare waste) - Другое Collection of serious post-operative complications
Collection of serious post-operative complications
Первичные конечные точки
- Occurrence of a serious postoperative complication [Срок оценки: 48 months]
Вторичные конечные точки (7)
- Determine the microbiological composition of saliva [Срок оценки: 48 months]
- Determine the components of the microbiota of periodontal plaque [Срок оценки: 48 months]
- Oral health assessment [Срок оценки: 48 months]
- Evaluation of hygiene and dietary habits [Срок оценки: 48 months]
- Determine the inflammatory composition of saliva [Срок оценки: 48 months]
- Determine the immune composition of saliva [Срок оценки: 48 months]
- Determine the microbiological composition of feces [Срок оценки: 48 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Patients infected with HIV
- Age under 18
- Under court supervision, guardianship, or curatorship
- Patients with a history of infective endocarditis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Франция · 1 центр
- Rangueil Hospital — Toulouse
Идентификаторы
NCT: NCT07075601 · RC31/25/0020 · 2025-A00422-47