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临床试验/NCT07075601
NCT07075601招募中不适用

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

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月19日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Occurrence of a serious postoperative complication

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients infected with HIV
  • Age under 18
  • Under court supervision, guardianship, or curatorship
  • Patients with a history of infective endocarditis.

研究组 & 干预措施

Patients with an indication for cardiac surgery

Experimental

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

干预措施: Take 1 ml of blood (Biological)

Patients with an indication for cardiac surgery

Experimental

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

干预措施: DNA sequencing (Biological)

Patients with an indication for cardiac surgery

Experimental

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

干预措施: Valve collection (healthcare waste) (Procedure)

Patients with an indication for cardiac surgery

Experimental

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

干预措施: Collection of serious post-operative complications (Other)

结局指标

主要结局

Occurrence of a serious postoperative complication

时间窗: 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

次要结局

  • Determine the microbiological composition of saliva(48 months)
  • Determine the components of the microbiota of periodontal plaque(48 months)
  • Oral health assessment(48 months)
  • Evaluation of hygiene and dietary habits(48 months)
  • Determine the inflammatory composition of saliva(48 months)
  • Determine the immune composition of saliva(48 months)
  • Determine the microbiological composition of feces(48 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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