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NCT Number: NCT06484036

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

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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Key information

Conditions

Severe Periodontitis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Mouth Diseases Nervous System Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

periodontal treatment strategy

Procedure

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

Primary outcomes

  1. Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

    Time frame: 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).

  2. Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

    Time frame: 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 outcomes

  1. Absolute change on Target-to-Background (TBR) ratio

    Time frame: 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).

  2. Proportion of TBR success becomes <1.6

    Time frame: At 6 months

  3. cardiovascular event

    Time frame: At 12 months

  4. ischemic stroke

    Time frame: At 12 months

  5. Atherothrombotic event

    Time frame: At 12 months

  6. Acute coronary syndrome

    Time frame: At 12 months

  7. Limb ischemia

    Time frame: At 12 months

  8. Mortality

    Time frame: At 12 months

  9. Difference in hs-CRP measurement

    Time frame: 6 months and 12 months

  10. Difference in Lp-PLA2 measurement

    Time frame: 6 months and 12 months

  11. Serious and non-serious adverse events

    Time frame: up to 12 Months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PerioStroke

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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