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

NCT06484036 | Not Yet Recruiting

• 1 other identifier: APHP230861
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Periodontitis; Ischemic Stroke

Keywords

PET scan; Severe Periodontitis; Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

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

  At 6 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

Study Arms (2)

Group with periodontal treatment strategy

EXPERIMENTAL

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

Procedure: periodontal treatment strategy

Group without periodontal treatment

NO INTERVENTION

Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke

Interventions

periodontal treatment strategy PROCEDURE

Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization

Group with periodontal treatment strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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)
• Pregnant or breastfeeding woman Patient under AME (state medical aid)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Periodontitis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 3, 2024

Record last verified: 2024-05