NCT06383208

Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics

Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 470 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Chronic Kidney Diseases
• Coronary Heart Disease
• Lipid Metabolism Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

1 site across 1 country: China