NCT04046237 Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
| NCT ID | NCT04046237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2019-08-02 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2019-08-02 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Philippe Gabriel STEG
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04046237 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Acute Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04046237 currently recruiting?
Yes, NCT04046237 is actively recruiting participants. Contact the research team at gabriel.steg@aphp.fr for enrollment information.
Where is the NCT04046237 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04046237 clinical trial?
NCT04046237 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Philippe Gabriel STEG at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 210 participants.