Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).
研究概览
简要总结
The present study was designed to determine the prevalence of previously unknown impaired glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial infarction subjected to acute PCI. Secondary, a possible association between inflammation, haemostasis and abnormal glucose regulation was studied.
详细描述
Background: A high prevalence of impaired glucose tolerance (IGT) and unknown diabetes mellitus (DM) in patients with cardiovascular disease has been shown. European guidelines recommend screening of patients with AMI for DM and IGT by performing an oral glucose tolerance test (OGTT). The prevalence of IGT and DM in a Norwegian population of patients with AMI is unknown. Evidence are lacking regarding the reliability of an OGTT performed early after an AMI. The present study was designed to detect unknown IGT and DM in patients with AMI and the main challenge of the study was timing and reproducibility of the OGTT. In addition, mechanisms (inflammation, haemostasis) involved in impaired glucose regulation will be studied. Design: The study is designed as an observational cohort study prospectively including 200 patients with a primary PCI treated acute STEMI admitted to the coronary care unit at Ullevål university hospital. An OGTT is performed in-hospital and repeated after 3 months and a glucometabolic classification was performed according to the results. The patients will be followed for a minimum of two-years with regards to clinical endpoints.
Aims of the study:
- Study the prevalence of IGT and DM in a Norwegian population with acute STEMI.
- Validate the results of an OGTT performed early after myocardial infarction, by repeating the test after three months.
- Elucidate possible interactions between biomarkers of inflammation and coagulation, and the glucometabolic status.
- Study the relationship between impaired glucose tolerance and prognosis after STEMI.
- Contribute to an increased focus on undiagnosed DM and IGT in patients with coronary heart disease in Norway and the results may lead to an increased use of routine OGTT in the follow-up of patients with myocardial infarction. Investigate how patients with myocardial infarction and known glucometabolic state are followed up "in real-life" by their physicians.
Clinical implications: The study may detect a large proportion of undetected DM and IGT in patients with AMI and change present guidelines on the follow-up of patients after AMI with increased focus on impaired glucose tolerance. The study will provide new insights about the association between inflammation, haemostasis and impaired glucose tolerance in patients with acute ST-elevation myocardial infarction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.
- •Stable patients
排除标准
- •unstable patient
- •signs of heart failure
- •renal failure defined as creatinine >200 umol/l
结局指标
主要结局
The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).
时间窗: Three-months after an acute ST-elevation myocardial infarction (STEMI).
次要结局
- Study the relationship between abnormal glucose regulation and prognosis after STEMI.(Two years)
- Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.(Three months)
- Validate the results of an OGTT performed early after myocardial infarction,(Repeating the test after three months.)