Clinical trial NCT04046237: Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Official title: Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Severe Periodontitis
Carotid Atherosclerosis
Keywords: Acute Myocardial Infarction
Severe Periodontitis
FDG-PET
Carotid Atherosclerosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2019-08-06
Enrollment: 210
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group.

For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9.

All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.

Detailed description: Eligible adults 30 to 70 years old hospitalized for an MI, (cf inclusion and non-inclusion criteria), will be asked to participate in the study. (screening)

At M0 :

* patients will be examined by a periodontist for assessing the severity of periodontitis (standard oral examination including a periodontal screening test).
* Patients with severe periodontitis will then receive: Complete periodontal examination of all teeth (6 sites per tooth) including pocket depth measurement, measurement of gingival recession, plaque index, gingival bleeding index, and a gingival fluid sample. Patients will then be informed of their periodontal status and therapeutic options. At this point, the patient may decide not to follow the treatment and will not be randomized.
* Patients who agree to continue the study will have a venous blood sample and a PET-FDG examination. Patients in whom the acquisition of FDG-PET is impossible will not be randomized.

At the end of these examinations, if all the conditions are met, the randomization will be carried out :

* Intervention group: Periodontal treatment, for a maximum of 6 months. At the end of the periodontal treatment, a follow-up of at least 6 months, including a maintenance visit to M9, will be performed.
* Control group: patients will be referred to their treating dentist for usual care.

At M12 (+12 months) : All patients (intervention group and control group) will have the same tests as M0

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for an acute myocardial infarction and included in the Frenchie registry
* Score ≥ 5 on the screening questionnaire for periodontitis
* Six teeth at least (excluding wisdom teeth)
* Consent signature
* Affiliation to a French medical insurance (Sécurité Sociale)

Exclusion Criteria:

* Patients with diseases,other than cardiovascular and diabetes, known to change the periodontal state such as AIDS, rheumatoid arthritis, Chediak-Higashi syndrome, Papillon-Lefèvre
* Systemic antibiotic therapy\> 48 hours in the 3 months prior to inclusion
* Acute heart failure
* Uncontrolled ventricular rhythm disorders
* Impossibility for the patient to attend follow-up visits
* Impossibility to maintain the extended position for 20 minutes
* Immunosuppressive therapy\> 1 month in the 6 months prior to inclusion
* Pregnancy, breastfeeding
* Known hypersensitivity to chlorhexidine, povidone, 18-fluoro-deoxyglucose

Primary outcomes:
measure: Effect of treatment of severe periodontitis in patients with an AMI
timeFrame: 12 months (+12months) after randomization
Secondary outcomes:
measure: Effect of treatment of severe periodontitis in patients with an AMI
timeFrame: 12 months (+12months) after randomization
measure: Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone
timeFrame: 12 months (+12months) after randomization
measure: Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta
timeFrame: 12 months (+12months) after randomization
measure: Dysbiosis
timeFrame: 12 months (+12months) after randomization
measure: CD31 in plasma and gingival fluid
timeFrame: 12 months (+12months) after randomization
measure: Inflammatory markers concentrations in the gingival fluid and in the plasma
timeFrame: 12 months (+12months) after randomization
measure: Evaluation of overall inflammation in vascular arteries
timeFrame: At randomization
measure: Evaluation of TBR measurments according to glycemia values
timeFrame: 12 months (+12months) after randomization
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat, AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Gabriel STEG
role: PRINCIPAL_INVESTIGATOR
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