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

June 28, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

157

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group with periodontal treatment strategy
Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke
Procedure: periodontal treatment strategy
Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization
No Intervention: Group without periodontal treatment
Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 6 months
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).
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 6 months
Proportion of TBR success becomes <1.6
Time Frame: At 6 months
At 6 months
cardiovascular event
Time Frame: At 12 months
At 12 months
ischemic stroke
Time Frame: At 12 months
At 12 months
Atherothrombotic event
Time Frame: At 12 months
At 12 months
Acute coronary syndrome
Time Frame: At 12 months
At 12 months
Limb ischemia
Time Frame: At 12 months
At 12 months
Mortality
Time Frame: At 12 months
At 12 months
Difference in hs-CRP measurement
Time Frame: 6 months and 12 months
6 months and 12 months
Difference in Lp-PLA2 measurement
Time Frame: 6 months and 12 months
6 months and 12 months
Serious and non-serious adverse events
Time Frame: up to 12 Months
up to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230861

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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