Clinical trial NCT04012541: Comprehensive Oral Intervention in Patients With AMI
Official title: A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Dental Diseases
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2019-07-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is randomized controlled trial. Patients who agreed to the study were randomly assigned to the intervention group and control group at a 1: 1 ratio.
Primary purpose: PREVENTION

Brief summary: The investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction.

The purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.

Detailed description: Subjects were divided into a treatment group and a control group. Both sides receive basic periodontal examinations, but the treatment group receives active dental procedure such as scaling and root planing. Both groups also receive post-myocardial infarction management.

As part of a pilot study, this study used the primary outcome measure for changes in surrogate markers rather than clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Adults over 18
* Patients diagnosed with type 1 or 2 MI according to the Fourth Universal Definition of Myocardial Infarction (2018) criteria
* Patients with baseline hsCRP (high-sensitivity C-reactive protein) elevated above 1.0 mg / dL

Exclusion Criteria:

1. clinical exclusion criteria

   * Inability to provide informed consent
   * Patients who are predicted to have low compliance
   * Those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons
   * Those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding
   * Those who need active dental treatment such as extraction
   * Patients suspected of having active infection
   * Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment
2. periodontal exclusion criteria

   * Fully edentulous (Except for fixed implant restorations)
   * If more than 15 teeth and implants do not exist
   * If the last dental visit experience is less than 6 months
   * If periodontal treatment is not possible by the researcher

Primary outcomes:
measure: hsCRP
timeFrame: at 3 months
Secondary outcomes:
measure: surrogate blood markers
timeFrame: at 3 months
measure: patient symptom
timeFrame: at 3 months & 12 months
measure: Systolic & diastolic blood pressure
timeFrame: at 3 months & 12 months
measure: Exercise performance
timeFrame: at 3 months
measure: Death
timeFrame: at 12 months
measure: unscheduled coronary revascularization
timeFrame: at 12 months
measure: stroke
timeFrame: at 12 months
measure: HF admission
timeFrame: at 12 months
measure: unstable angina
timeFrame: at 12 months
measure: recurrent MI
timeFrame: at 12 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Si-Hyuck Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.