Clinical trial NCT06484036: Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Periodontitis
Ischemic Stroke
Keywords: PET scan
Severe Periodontitis
Ischemic Stroke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, open-label, randomized controlled superiority trial in 2 parallel groups with adjudication of the primary endpoint blinded to the randomization group and centrally (PET reading).
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
timeFrame: At 6 months
measure: Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
timeFrame: At 6 months
Secondary outcomes:
measure: Absolute change on Target-to-Background (TBR) ratio
timeFrame: At 6 months
measure: Proportion of TBR success becomes <1.6
timeFrame: At 6 months
measure: cardiovascular event
timeFrame: At 12 months
measure: ischemic stroke
timeFrame: At 12 months
measure: Atherothrombotic event
timeFrame: At 12 months
measure: Acute coronary syndrome
timeFrame: At 12 months
measure: Limb ischemia
timeFrame: At 12 months
measure: Mortality
timeFrame: At 12 months
measure: Difference in hs-CRP measurement
timeFrame: 6 months and 12 months
measure: Difference in Lp-PLA2 measurement
timeFrame: 6 months and 12 months
measure: Serious and non-serious adverse events
timeFrame: up to 12 Months
Other outcomes:
Locations:
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