Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Recruiting now · Not applicable
Conditions studied: Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis
In brief
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.
Key facts
- Study ID
- NCT04046237
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 210
- Starts
- 2019-08-02
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-09-08
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Hôpital Bichat, AP-HP — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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