Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI) (PAROCARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046237
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Severe Periodontitis Carotid Atherosclerosis Other: Periodontal treatment Not Applicable

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 : All patients (intervention group and control group) will have the same tests as M0


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Estimated Study Start Date : August 2, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
No Intervention: Usual treatment - Control group

The patient is referred to his treating dentist with a diagnosis report of his oral state including his periodontal status.

The usual care usually includes the extraction of non-preservable teeth, the dental prosthesis to replace them and at least one descaling session.

Experimental: Periodontal treatment - Intervention group

Periodontal treatment can last up to 6 months depending on the periodontal state, followed by a follow-up period of at least 6 months including a visit at M9.

Briefly, the intervention group includes initial therapy with information on oral hygiene techniques, scaling and surfacing of dental roots. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year.

Other: Periodontal treatment

Periodontal treatment can last up to 6 months depending on the periodontal state, followed by a follow-up period of at least 6 months including a visit to M9.

Briefly, the intervention group includes initial therapy in 48 hours maximum which includes information on oral hygiene techniques (verbal + brochure), scaling and surfacing of dental roots with antiseptic irrigation and non-tooth extraction. retainable. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year.





Primary Outcome Measures :
  1. Effect of treatment of severe periodontitis in patients with an AMI [ Time Frame: 12 months after randomization ]
    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


Secondary Outcome Measures :
  1. Effect of treatment of severe periodontitis in patients with an AMI [ Time Frame: 12 months after randomization ]
    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

  2. Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone [ Time Frame: 12 months after randomization ]
    Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone

  3. Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta [ Time Frame: 12 months after randomization ]
    Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta

  4. Dysbiosis [ Time Frame: 12 months after randomization ]
    Changes in the dysbiosis index

  5. CD31 in plasma and gingival fluid [ Time Frame: 12 months after randomization ]
    Changes in concentrations of soluble CD31 in plasma and the gingival fluid

  6. Inflammatory markers concentrations in the gingival fluid and in the plasma [ Time Frame: 12 months after randomization ]
    Changes in the inflammatory markers including IL-1β, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma

  7. Evaluation of overall inflammation in vascular arteries [ Time Frame: At randomization ]
    Correlation between soluble CD31 / cleaved CD31 ratio and TBR

  8. Evaluation of TBR measurments according to glycemia values [ Time Frame: 12 months after randomization ]
    Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046237


Contacts
Layout table for location contacts
Contact: Philippe Gabriel STEG 01 40 25 80 80 gabriel.steg@aphp.fr

Locations
Layout table for location information
France
Hôpital Bichat, AP-HP Recruiting
Paris, France
Contact: Philippe Gabriel STEG    01 40 25 80 80    gabriel.steg@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Research Agency, France
Investigators
Layout table for investigator information
Principal Investigator: Philippe Gabriel STEG Assistance Publique - Hôpitaux de Paris

Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04046237     History of Changes
Other Study ID Numbers: P 171104
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Myocardial Infarction
Severe Periodontitis
FDG-PET
Carotid Atherosclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Artery Diseases
Arterial Occlusive Diseases
Periodontitis
Myocardial Infarction
Atherosclerosis
Infarction
Plaque, Atherosclerotic
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical