Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lipid metabolomics.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Coronary Heart Disease, Lipid Metabolism Disorders. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
Overview
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.
Interventions
- Diagnostic test lipid metabolomics
Extract 4 milliliters of fasting peripheral venous blood from enrolled patients for targeted lipid metabolism metabolomics research. Utilize a liquid chromatography-tandem mass spectrometry (LC-MS/MS) system to conduct metabolomics analysis on patient blood samples.
Primary outcome measures
- Incidence of cardiovascular adverse events [Time frame: 12 month follow-up]
- Incidence of Renal composite endpoint event [Time frame: 12 month follow-up]
Secondary outcome measures (3)
- Incidence of All-cause mortality [Time frame: 12 month follow-up]
- Incidence of Repeat revascularization [Time frame: 12 month follow-up]
- Incidence of bleeding [Time frame: 12 month follow-up]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06383208 · 2024-ZF-13