A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China - 3B Extension A Study of China Cardiometabolic Registries (CCMR)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 主要终点
- Incidence of CVD events
研究概览
简要总结
In 2010, the sponsor conducted an observational study, entitled as "Nationwide Assessment of Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese Patients with Type 2 Diabetes - 3B Study " which was to evaluate the level of cardiovascular diseases (CVD) risk factor control and its regional difference in China. As a continuation, this extension of the 3B Study is designed to assess the incidence of cardiovascular events, cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients with type 2 diabetes and with high risk of (CVD) with or without existing or history of coronary artery diseases.
详细描述
Limited by its cross sectional design, 3B study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. This information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors.
The 3B Extension study is thus designed to extend the 3B study by continuing to follow up on enrolled patients for 3 years. The 3B Extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. It will be the first study of this scale in China based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. It will be conducted in collaboration with the advisory board of China Cardiometabolic Registries (CCMR).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Outpatients who meet the inclusion and exclusion criteria of 3B study
- •With hypertension,dyslipidemia and one of the following:
- •History of acute coronary artery disease or ischemic stroke
- •Age > 65 years old
- •Overweight or obesity (BMI > 24 kg/m2)
- •Microalbuminuria or albuminuria
- •Current smoker
排除标准
- •Patients with type 1 DM
- •Pregnant or breast feeding women
- •Patients who are unable to or not willing to return for follow up visits every 6 months for 3 years;
- •Patients have severe heart failure (NYHA Class III-IV)
- •Patients with severe renal deficiency (creatinine clearance < 30 ml/min)
- •Patients who are not willing to sing the informed consent form;
- •Patients who are participating in any other interventional clinical studies,
结局指标
主要结局
Incidence of CVD events
时间窗: 3 years
The CVD event is defined as composite of : * Acute myocardial infarction * Stroke * Cardiovascular death
次要结局
- Annual incidence of microvascular complications(3 years)