A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- hsCRP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
control group
- post-myocardial infarction management
- basic periodontal examinations
干预措施: post-myocardial infarction management (Drug)
treatment group
- post-myocardial infarction management
- basic periodontal examinations
- active dental procedure
干预措施: active dental procedure (Procedure)
treatment group
- post-myocardial infarction management
- basic periodontal examinations
- active dental procedure
干预措施: post-myocardial infarction management (Drug)
treatment group
- post-myocardial infarction management
- basic periodontal examinations
- active dental procedure
干预措施: basic periodontal examinations (Radiation)
control group
- post-myocardial infarction management
- basic periodontal examinations
干预措施: basic periodontal examinations (Radiation)
结局指标
主要结局
hsCRP
时间窗: at 3 months
hsCRP(high sensitivity C-reactive protein), mg/dL
次要结局
- HF admission(at 12 months)
- unstable angina(at 12 months)
- unscheduled coronary revascularization(at 12 months)
- recurrent MI(at 12 months)
- patient symptom(at 3 months & 12 months)
- surrogate blood markers(at 3 months)
- Systolic & diastolic blood pressure(at 3 months & 12 months)
- Exercise performance(at 3 months)
- Death(at 12 months)
- stroke(at 12 months)
研究者
Si-Hyuck Kang
Professor
Seoul National University Bundang Hospital