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

Not Applicable

Not yet recruiting

• Conditions: Severe Periodontitis; Ischemic Stroke
• Interventions: Procedure: periodontal treatment strategy

• Registration Number: NCT06484036
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Start: 2024-09-01
• Primary Completion: 2028-03-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 157

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with periodontal treatment strategy	periodontal treatment strategy	Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acute coronary syndrome	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
Limb ischemia	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
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).
Mortality	At 12 months