Dietary Intervention for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Events of cardiovascular diseases at Year 6.
研究概览
简要总结
Incidence of cardiometabolic disease (CMD) continues to rise, which consumes huge medical resources in Taiwan. The effectiveness of dietary therapy for CMD has not been locally evaluated in detail. CVD is an important risk factor for dementia. At the present time, there is no effective treatment available for dementia. Early prevention is extremely important. Our previous studies have shown that Taiwanese dementia protective diet is very similar to cardiovascular prevention and control diet, meaning that effective dietary therapy may not only control CVD but also prevent dementia development. Therefore, this study intends to document the effects of dietary intervention on cardiovascular disease risk factor control, the long-term outcomes on the occurrence of cardiovascular events, and the maintenance of cognitive function for patients with coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received percutaneous transluminal coronary artery surgery.
- •Stable drug control for more than one month
排除标准
- •Suffer from cancer and undergo chemotherapy or surgery within one year.
- •Those who have a major illness in hospital within one year.
- •Those with kidney disease stage 5 (inclusive) or above
- •Those whose life expectancy does not exceed half a year
- •Patients with diagnosed dementia
- •Those who do not want to be tracked
结局指标
主要结局
Events of cardiovascular diseases at Year 6.
时间窗: Year 6.
CVD or non-CVD death, stroke, acute myocardial infarction, hospitalization for acute coronary syndrome, hospitalization for coronary intervention surgery, hospitalization for various cardiovascular diseases, hospitalization for heart failure, hospitalization for other CVD diseases, new-onset heart arrhythmia, new-onset peripheral blood vessels block
Change from baseline in diet quality at Year 1, 2, and 3.
时间窗: Baseline, year 1, 2 and 3
Diet quality is estimated according to the daily intake of nutrients and the distribution of the six food groups, with a qualified food frequency questionnaire. The six food groups include: 1. Whole grains and starchy vegetables 2. Protein foods: soybeans, fish, eggs, and meat 3. Vegetables 4. Fruits 5. Dairy 6. Oils, nuts \& seeds
Change from baseline in concentrations of cardiovascular risk factors at Month 6, 12, 18, 24,30, and 36.
时间窗: Baseline and Month 6, 12, 18, 24, 30, and 36.
Cardiovascular risk factors include total cholesterol,triglyceride, low-density lipoprotein ,high-density lipoprotein, uric acid, glucose, HbA1C.
次要结局
- Change from baseline in the number of digits at Year 1, 2 and 3.(Baseline, year 1, 2 and 3.)
- Change from baseline in scores of Montreal Cognitive Assessment at Year 1, 2, and 3.(Baseline, year 1, 2 and 3.)
- Change from baseline in scores of Number Cancellation test(Baseline, year 1, 2 and 3.)
- Change from baseline in the dosage of prescribed drugs at Month 6, 12, 18, 24,30, and 36.(Baseline and Month 6, 12, 18, 24, 30, and 36.)
- Change from baseline in cardiovascular risk score(Baseline, year 1, 2 and 3.)
- Change from baseline in concentrations of inflammatory markers at Year 1, 2, and 3.(Baseline, year 1, 2 and 3.)
研究者
Wen-Harn Pan
Distinguished Research Fellow, Principal Investigator
Academia Sinica, Taiwan