Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,042
- 试验地点
- 1
- 主要终点
- Primary end point all cause death
研究概览
简要总结
Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.
详细描述
We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the patients who are according with the II、III stage in CHD western medical diagnosis standard；
- •age between 18 and 75(including 18 and 75)；
- •Signed the informed consent voluntarily.
排除标准
- •The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
- •the patients who have myocardial infarction or vascular remodeling in last 3 months；
- •hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；
- •the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）；
- •the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
- •any other sever diseases such as malignant tumor；
- •the patients who attending other clinical study in late 3 months；
- •pregnant or lactating women；
- •the patients who have allergic constitution or are allergic to many drugs.
结局指标
主要结局
Primary end point all cause death
时间窗: up to 12 months
all because of death, stroke, nonfatal myocardial infarction, revascularization.
Secondary endpoint hospitalization
时间窗: up to 12months
the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
次要结局
- electrocardiogram(up to 12months)
- Angina symptoms(up to 12months)
研究者
yue deng
Director of cardiology department
Changchun University of Chinese Medicine