Acute Myocardial Infarction Clinical Trial
Official title:
A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | National Research Foundation of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hsCRP | hsCRP(high sensitivity C-reactive protein), mg/dL | at 3 months | |
Secondary | surrogate blood markers | FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL | at 3 months | |
Secondary | patient symptom | NYHA functional class | at 3 months & 12 months | |
Secondary | Systolic & diastolic blood pressure | automated blood pressure, mmHg | at 3 months & 12 months | |
Secondary | Exercise performance | Treadmill test | at 3 months | |
Secondary | Death | number of cardiovascular death | at 12 months | |
Secondary | unscheduled coronary revascularization | number of unscheduled coronary revascularization | at 12 months | |
Secondary | stroke | number of stroke | at 12 months | |
Secondary | HF admission | number of HF admission | at 12 months | |
Secondary | unstable angina | number of unstable angina | at 12 months | |
Secondary | recurrent MI | number of recent MI | at 12 months |
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