NCT06484036Not yet recruiting
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 157 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT06484036
What you commit to
- Study type: Interventional
- Planned participants: 157
- From 1 Sept 2024 to the primary completion date, 1 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplant pending
- Participation in another interventional research involving humans or being in the exclusion period following previous research involving humans
Other illness
- Known allergy to fluoro-deoxyglucose and its excipient
- Uncontrolled diabetes
- Progressive infectious diseases
Other
- \< 6 teeth
- Without independent oral hygiene
- Contraindications to PET scan
- Immunosuppressive treatment
- High risk of infective endocarditis
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.