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

Primary Purpose

Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Periodontal treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Severe Periodontitis, FDG-PET, Carotid Atherosclerosis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Bichat, AP-HPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual treatment - Control group

Periodontal treatment - Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Dysbiosis
Changes in the dysbiosis index
CD31 in plasma and gingival fluid
Changes in concentrations of soluble CD31 in plasma and the gingival fluid
Inflammatory markers concentrations in the gingival fluid and in the plasma
Changes in the inflammatory markers including IL-1β, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma
Evaluation of overall inflammation in vascular arteries
Correlation between soluble CD31 / cleaved CD31 ratio and TBR
Evaluation of TBR measurments according to glycemia values
Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET

Full Information

First Posted
August 2, 2019
Last Updated
April 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT04046237
Brief Title
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Acronym
PAROCARD
Official Title
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis
Keywords
Acute Myocardial Infarction, Severe Periodontitis, FDG-PET, Carotid Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual treatment - Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Periodontal treatment - Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Periodontal treatment
Intervention Description
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 Measure Information:
Title
Effect of treatment of severe periodontitis in patients with an AMI
Description
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
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Effect of treatment of severe periodontitis in patients with an AMI
Description
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
Time Frame
12 months after randomization
Title
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone
Description
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone
Time Frame
12 months after randomization
Title
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta
Description
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta
Time Frame
12 months after randomization
Title
Dysbiosis
Description
Changes in the dysbiosis index
Time Frame
12 months after randomization
Title
CD31 in plasma and gingival fluid
Description
Changes in concentrations of soluble CD31 in plasma and the gingival fluid
Time Frame
12 months after randomization
Title
Inflammatory markers concentrations in the gingival fluid and in the plasma
Description
Changes in the inflammatory markers including IL-1β, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma
Time Frame
12 months after randomization
Title
Evaluation of overall inflammation in vascular arteries
Description
Correlation between soluble CD31 / cleaved CD31 ratio and TBR
Time Frame
At randomization
Title
Evaluation of TBR measurments according to glycemia values
Description
Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Gabriel STEG
Phone
01 40 25 80 80
Email
gabriel.steg@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gabriel STEG
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat, AP-HP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Gabriel STEG
Phone
01 40 25 80 80
Email
gabriel.steg@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

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