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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2024
  • participants needed
    135
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 April 2022
myocardial infarction
18f-fdg
fdg-pet

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.

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

Details
Condition Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis
Treatment Periodontal treatment
Clinical Study IdentifierNCT04046237
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note