Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Incidence of cardiovascular adverse events
研究概览
简要总结
Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.
Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years old;
- •Diagnosed with CHD during hospitalization through coronary angiography, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation acute coronary syndrome (NST-ACS), stable angina pectoris;
- •Patients with clarified renal function status.;
- •CKD is defined as meeting one of the following criteria, with a duration of more than 3 months: eGFR < 60 ml/min/1.73 m² or eGFR ≥ 60 ml/min/1.73 m² and urinary albumin-to-creatinine ratio (uACR) ≥ 30 mg/g;
排除标准
- •Pregnancy or lactation;
- •Severe valve disease or severe mechanical complications requiring surgical intervention;
- •Severe psychiatric illness or other reasons that impede follow-up compliance;
- •Severe hematologic disorders or end-stage malignant tumors;
- •Having undergone kidney transplantation or long-term maintenance dialysis;
- •Severe liver disease (Child-Pugh class C);
- •Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;
- •Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;
- •Life expectancy less than 1 year.
结局指标
主要结局
Incidence of cardiovascular adverse events
时间窗: 12 month follow-up
Cardiovascular adverse events includes Cardiovascular-related death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, rehospitalization for heart failure. 1. Cardiovascular events related to mortality: This includes 1) cardiovascular death; 2) death caused by stroke; 3) death resulting from cardiovascular surgery; 4) death from other cardiovascular causes. 2. Cardiovascular death: During the follow-up period, this refers to death directly associated with documented myocardial infarction, heart failure, or arrhythmia. It also includes death events where the cause is unclear and not attributed to any other underlying conditions. 3. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG;
Incidence of Renal composite endpoint event
时间窗: 12 month follow-up
Renal composite endpoint event includes renal failure, renal-related death, or a decrease in eGFR \>40% from baseline (confirmed by a second test 4 weeks later). 1. Renal failure: End-stage kidney disease (ESKD) or eGFR persistently below 15 ml/min/1.73 m². 2. End-stage kidney disease: Receiving renal replacement therapy (RRT), including hemodialysis/peritoneal dialysis, for more than 3 months, or undergoing kidney transplantation. Acute kidney injury (AKI) events leading to dialysis and death are also considered end-stage kidney disease (ESKD) events. 3. Renal-related death: Meeting both of the following criteria: 1) The patient died during the follow-up period; 2) Despite the need for renal replacement therapy (RRT) due to their condition, it was not received；3）No other clear cause of death.
次要结局
- Incidence of bleeding(12 month follow-up)
- Incidence of All-cause mortality(12 month follow-up)
- Incidence of Repeat revascularization(12 month follow-up)
研究者
Jingang Zheng
Department of Cardiology, China-Japan Friendship Hospital
China-Japan Friendship Hospital