Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke

Официальное название

Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke: a Multicenter Randomized Controlled Trial: a Multicenter Randomized Controlled Trial

Обзор

Cardiovascular disease is the world's leading cause of death. Atherothrombosis is a common cause of ischemic stroke. A strong epidemiological link has been established between periodontitis and the risk of stroke. It shares common risk factors with atherothrombosis, and its severe form is associated with low-grade systemic inflammation and daily low-intensity bacteremia. Atherothrombosis is a frequent cause of ischemic stroke. Periodontal bacteria have been found within atheromatous plaques, correlated with a greater risk of rupture. Thus, periodontitis could be a modifiable risk factor for atherothrombosis and future vascular events: its early diagnosis and treatment could have a major impact on cardiovascular prevention. Hypothesis: In patients with periodontitis who have had an ischemic stroke, periodontal treatment may reduce atherosclerotic plaque activity.

Вмешательства

• Процедура periodontal treatment strategy
  Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization

Первичные конечные точки

• Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold). [Срок оценки: At 6 months]
• Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold). [Срок оценки: At 6 months]

Вторичные конечные точки (11)

• Absolute change on Target-to-Background (TBR) ratio [Срок оценки: At 6 months]
• Proportion of TBR success becomes <1.6 [Срок оценки: At 6 months]
• cardiovascular event [Срок оценки: At 12 months]
• ischemic stroke [Срок оценки: At 12 months]
• Atherothrombotic event [Срок оценки: At 12 months]
• Acute coronary syndrome [Срок оценки: At 12 months]
• Limb ischemia [Срок оценки: At 12 months]
• Mortality [Срок оценки: At 12 months]
• Difference in hs-CRP measurement [Срок оценки: 6 months and 12 months]
• Difference in Lp-PLA2 measurement [Срок оценки: 6 months and 12 months]
• Serious and non-serious adverse events [Срок оценки: up to 12 Months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Minor ischemic stroke of the anterior circulation (NIHSS ≤ 5) of atherothrombotic origin according to the TOAST scale <30 days
• Atheroma plaque of the ipsilateral carotid bulb >30% not eligible for intervention (endarterectomy or angioplasty-stenting)
• Severe periodontitis (stage 3 or 4)
• Signed informed consent
• Affiliation to a social security scheme

Критерии исключения

• < 6 teeth
• Without independent oral hygiene
• Contraindications to PET scan
• Known allergy to fluoro-deoxyglucose and its excipient
• Immunosuppressive treatment
• Uncontrolled diabetes
• High risk of infective endocarditis
• Organ transplant pending
• Progressive infectious diseases
• Active smoking not stopped
• Patient deprived of liberty by judicial or administrative decision
• Patient under legal protection (guardianship, curatorship)
• Participation in another interventional research involving humans or being in the exclusion period following previous research involving humans
• Pregnant or breastfeeding woman Patient under AME (state medical aid)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06484036 · APHP230861

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗