Acute Myocardial Infarction, Dental Diseases
Conditions
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.
Interventions
PROCEDUREactive dental procedure
scaling and root planing
DRUGpost-myocardial infarction management
aspirin, clopidogrel, ticagrelor
RADIATIONbasic periodontal examinations
panorama radiograph : full mouth periapical radiograph
Sponsors
National Research Foundation of Korea
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Participating patients and dentists are not able to blind information about random allocation. However, in order to reduce the bias, the cardiologist who treats the patient and prescribes the medicines performs an investigator-masked design that masks information about the treatment group.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP | at 3 months | hsCRP(high sensitivity C-reactive protein), mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient symptom | at 3 months & 12 months | NYHA functional class |
| Systolic & diastolic blood pressure | at 3 months & 12 months | automated blood pressure, mmHg |
| Exercise performance | at 3 months | Treadmill test |
| Death | at 12 months | number of cardiovascular death |
| surrogate blood markers | at 3 months | FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL |
| stroke | at 12 months | number of stroke |
| HF admission | at 12 months | number of HF admission |
| unstable angina | at 12 months | number of unstable angina |
| recurrent MI | at 12 months | number of recent MI |
| unscheduled coronary revascularization | at 12 months | number of unscheduled coronary revascularization |
Countries
South Korea
Contacts
Primary ContactSi-Hyuck Kang, MD
Backup ContactJi Yeon Yoon
Outcome results
None listed