Acute Myocardial Infarction Clinical Trial
— PAROCARDOfficial title:
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
NCT number | NCT04046237 |
Other study ID # | P 171104 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2, 2019 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | December 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bichat, AP-HP | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | National Research Agency, France |
France,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of treatment of severe periodontitis in patients with an AMI | The primary endpoint will be the absolute difference of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity on carotid arteries between the initial PET scan and the PET scan performed at 12 months after randomization | 12 months after randomization | |
Secondary | Effect of treatment of severe periodontitis in patients with an AMI | Relative difference of the most-diseased segment (MDS) Tissue to Background ratio (TBR) ((M12-M0)/M0) of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity | 12 months after randomization | |
Secondary | Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone | Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone | 12 months after randomization | |
Secondary | Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta | Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta | 12 months after randomization | |
Secondary | Dysbiosis | Changes in the dysbiosis index | 12 months after randomization | |
Secondary | CD31 in plasma and gingival fluid | Changes in concentrations of soluble CD31 in plasma and the gingival fluid | 12 months after randomization | |
Secondary | Inflammatory markers concentrations in the gingival fluid and in the plasma | Changes in the inflammatory markers including IL-1ß, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma | 12 months after randomization | |
Secondary | Evaluation of overall inflammation in vascular arteries | Correlation between soluble CD31 / cleaved CD31 ratio and TBR | At randomization | |
Secondary | Evaluation of TBR measurments according to glycemia values | Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET | 12 months after randomization |
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