Severe PeriodontitisPerioStrokeNCT06484036
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
A study testing periodontal treatment strategy in people with Severe Periodontitis and Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Periodontitis, Ischemic Stroke
- What is being tested?
- periodontal treatment strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 6 teeth
- Without independent oral hygiene
- Contraindications to PET scan
- Known allergy to fluoro-deoxyglucose and its excipient
- Immunosuppressive treatment
- Uncontrolled diabetes
Show all 14Show fewer
- 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)
About this study
Official 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
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.
Read more
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
- Being tested
- periodontal treatment strategy
- Keywords
- PET scan, Severe Periodontitis, Ischemic Stroke
- Medical subject headings
- Periodontitis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatment strategyProcedure or surgery
Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization
| Study group | Role | What they receive |
|---|---|---|
| Group with periodontal treatment strategy | Experimental | Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke Receives: Procedure: periodontal treatment strategy |
| Group without periodontal treatment | No intervention | Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At 6 months
Secondary outcomes (11)
Absolute change on Target-to-Background (TBR) ratio
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).
Measured: At 6 months
Proportion of TBR success becomes <1.6
Measured: At 6 months
cardiovascular event
Measured: At 12 months
ischemic stroke
Measured: At 12 months
Atherothrombotic event
Measured: At 12 months
Acute coronary syndrome
Measured: At 12 months
Limb ischemia
Measured: At 12 months
Mortality
Measured: At 12 months
Difference in hs-CRP measurement
Measured: 6 months and 12 months
Difference in Lp-PLA2 measurement
Measured: 6 months and 12 months
Serious and non-serious adverse events
Measured: up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PeriodontitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484036
- Sponsor's protocol ID
- APHP230861
- Acronym
- PerioStroke
- Status last verified
- May 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06484036
- Acronym / sponsor ID
- PerioStroke / APHP230861
- Conditions
- Severe Periodontitis, Ischemic Stroke
- Keywords
- PET scan, Severe Periodontitis, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group with periodontal treatment strategy | Experimental | Procedure: periodontal treatment strategyGroup with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke |
| Group without periodontal treatment | No intervention | –Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- < 6 teeth
- Without independent oral hygiene
- Contraindications to PET scan
- Known allergy to fluoro-deoxyglucose and its excipient
- Immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal treatment strategyPeriodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization | Procedure or surgery | Group with periodontal treatment strategy |
Primary outcome
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).
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).
11 secondary outcomes
Absolute change on Target-to-Background (TBR) ratio
Time frame: At 6 months
Proportion of TBR success becomes <1.6
Time frame: At 6 months
cardiovascular event
Time frame: At 12 months
ischemic stroke
Time frame: At 12 months
Atherothrombotic event
Time frame: At 12 months
Acute coronary syndrome
Time frame: At 12 months
Limb ischemia
Time frame: At 12 months
Mortality
Time frame: At 12 months
Difference in hs-CRP measurement
Time frame: 6 months and 12 months
Difference in Lp-PLA2 measurement
Time frame: 6 months and 12 months
Serious and non-serious adverse events
Time frame: up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal treatment strategy in people with Severe Periodontitis and Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold). (time frame: At 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.