Treating severe gum disease to reduce inflammation in heart attack patients
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
This study is testing if treating severe gum disease can help reduce inflammation in heart attack patients' arteries and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04046237 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized clinical trial investigates the effects of periodontal therapy on inflammatory activity in atheromatous plaques among patients hospitalized for an acute myocardial infarction (AMI). Participants aged 30 to 70 with severe periodontitis will be randomly assigned to receive either specialized periodontal treatment or standard dental care. Both groups will undergo FDG-PET scans to evaluate inflammation in carotid atherosclerotic plaques at the beginning and after 12 months. The study aims to determine if improved oral health can positively impact cardiovascular inflammation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 70 who have been hospitalized for an acute myocardial infarction and diagnosed with severe periodontitis.
Not a fit: Patients with other significant health conditions affecting periodontal status or those unable to attend follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients with both severe periodontitis and acute myocardial infarction.
How similar studies have performed: While the specific approach of this study is novel, previous studies have suggested a link between periodontal health and cardiovascular disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Bichat, AP-HP — Paris, France (Recruiting)
Study contacts
- Principal investigator: Philippe Gabriel STEG — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Philippe Gabriel STEG
- Email: gabriel.steg@aphp.fr
- Phone: 01 40 25 80 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.