Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease: a Prospective, Multi-center, Hospital-based Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- prevalence of chronic kidney disease in patients with stable coronary heart disease
研究概览
简要总结
This is a prospective, multi-center, hospital-based observational study. The aim of the study is to evaluate the prevalence of chronic kidney disease in patients with stable coronar heart disease.
详细描述
The primary aim of the study is to evaluate the prevalence of chronic kidney disease(CKD) in patients with stable coronary heart disease. The secondary aims include: 1. To evaluate the awareness of CKD in patients with stable coronary heart disease. 2. To find out risk factors that is associated with CKD in these patients. 3. To evaluate the association between CKD and cardiovascular events during one-year's follow-up. Based on sample size estimation, the plan is to recruit 10000 patients from 100 centers. Patients who participate the study will finish one-year's follow up (0 day, 6 months and 12 months after recruitment). During the baseline visit, patients' demographic characters will be collected, and laboratory tests will be performed for urinalysis, renal function, hepatic function, etc. During the 6 months' follow up, MACE(Major adverse cardiovascular events) will be recorded through phone or face to face interview between investigators and patients. MACE include all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, documented re-hospitalization for unstable angina pectoris, and coronary revascularization (including percutaneous coronary intervention and CABG). During the 12 month's follow up, MACE will be recorded, and laboratory tests will be performed again.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years.
- •Patients with clinical evidence of stable coronary heart disease, who meet at least one of the following three criterias:
- •a. Stable coronary heart disease with objective evidence of atherosclerosis, either coronary angiography shows ≥50% stenosis of at least one of the coronary main stems or first-level branches, or typical exertional angina pectoris with positive stress tests(ECG stress test, echocardiograph stress test, or stress radionuclide myocardial imaging). b Diagnosed of myocardial infarction at least 3 months before recruitment. c.Coronary revascularization(PCI or CABG) at least 3 months before recruitment.
- •Informed consent signed by patients or legal guardians.
- •Willing to and capable of being followed up for 1 year.
排除标准
- •Non-atherosclerotic coronary heart disease
- •Deterioration of heart failure during the past 3 months
- •Exposed to contrast agent during the past one month.
- •History of amputation
- •Pregnancy
- •Female patients in menstrual period(still eligible after menstrual period)
- •Organ failure other than heart failure and kidney failure
- •Comorbid other diseases, and life expectancy <1 year
- •Considered not fit for the study due to other reasons, including but not restricted to : a. Severe infection; b. Acute kidney injury.
结局指标
主要结局
prevalence of chronic kidney disease in patients with stable coronary heart disease
时间窗: 1 year
After recruitment, urinalysis, urine albumin/creatinine ratio(ACR), and serum creatitine will be tested. Chronic kidney disease is defined as ≥1 of the following abnormalities: 1)estimated GFR\<60ml/min per1.73m2. The eGFR is estimated using the CKD-EPI equation ; 2) Presence of proteinuria. Proteinuria is defined as urine ACR \>30mg/g, or urinalysis showing positive proteinuria.
次要结局
- factors associated with chronic kidney disease in patients with stable coronary heart disease(1 year)
- the awareness rate of chronic kidney disease in patients with stable coronary heart disease(1 year)
- the association between CKD and cardiovascular events during one-year's follow-up(2 year)
研究者
Yong Huo
Director, Department of Cardiology
Peking University First Hospital