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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 157
- 主要终点
- Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •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
排除标准
- •< 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)
结局指标
主要结局
Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
时间窗: At 6 months
The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).
Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
时间窗: At 6 months
The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).
次要结局
- Acute coronary syndrome(At 12 months)
- Limb ischemia(At 12 months)
- Proportion of TBR success becomes <1.6(At 6 months)
- cardiovascular event(At 12 months)
- ischemic stroke(At 12 months)
- Atherothrombotic event(At 12 months)
- Difference in hs-CRP measurement(6 months and 12 months)
- Mortality(At 12 months)
- Difference in Lp-PLA2 measurement(6 months and 12 months)
- Serious and non-serious adverse events(up to 12 Months)
- Absolute change on Target-to-Background (TBR) ratio(At 6 months)