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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with periodontal treatment strategy | Experimental | Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke |
|
| Group without periodontal treatment | No Intervention | Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| periodontal treatment strategy | Procedure | Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 6 months |
| Number 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). | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 6 months |
| Proportion of TBR success becomes <1.6 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| At 6 months |
| cardiovascular event | At 12 months |
| ischemic stroke | At 12 months |
| Atherothrombotic event | At 12 months |
| Acute coronary syndrome | At 12 months |
| Limb ischemia | 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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