Ischemic Stroke, Severe Periodontitis
Conditions
Keywords
PET scan, Severe Periodontitis, Ischemic Stroke
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.
Interventions
PROCEDUREperiodontal treatment strategy
Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold). | 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change on Target-to-Background (TBR) ratio | At 6 months | 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). |
| Proportion of TBR success becomes <1.6 | At 6 months | — |
| Atherothrombotic event | At 12 months | — |
| Acute coronary syndrome | At 12 months | — |
| cardiovascular event | At 12 months | — |
| Mortality | At 12 months | — |
| Difference in hs-CRP measurement | 6 months and 12 months | — |
| Difference in Lp-PLA2 measurement | 6 months and 12 months | — |
| Serious and non-serious adverse events | up to 12 Months | — |
| Limb ischemia | At 12 months | — |
| ischemic stroke | At 12 months | — |
Outcome results
None listed