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

N/ANot Yet RecruitingNCT06484036

Assistance Publique - Hôpitaux de Paris157 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

157

Conditions

Severe Periodontitis Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * \< 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)

Outcomes

Primary Outcomes

Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

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).

Time frame: At 6 months

Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

Time frame: At 6 months

Secondary Outcomes

Absolute change on Target-to-Background (TBR) ratio

Nominal change in atherosclerotic plaque metabolic activity measured by Target-to-Background (TBR) ratio measured by PET scan after 18-FDG injection at 6 months versus at baseline (absolute change).

Time frame: At 6 months

Proportion of TBR success becomes <1.6

Time frame: At 6 months

cardiovascular event

Time frame: At 12 months

ischemic stroke

Time frame: At 12 months

Atherothrombotic event

Time frame: At 12 months

Acute coronary syndrome

Time frame: At 12 months

Limb ischemia

Time frame: At 12 months

Mortality

Time frame: At 12 months

Difference in hs-CRP measurement

Time frame: 6 months and 12 months

Difference in Lp-PLA2 measurement

Time frame: 6 months and 12 months

Serious and non-serious adverse events

Time frame: up to 12 Months