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

NCT ID: NCT06383208

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 470 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old;

2. 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;

3. 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

1. Pregnancy or lactation;

2. Severe valve disease or severe mechanical complications requiring surgical intervention;

3. Severe psychiatric illness or other reasons that impede follow-up compliance;

4. Severe hematologic disorders or end-stage malignant tumors;

5. Having undergone kidney transplantation or long-term maintenance dialysis;

6. Severe liver disease (Child-Pugh class C);

7. Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;

8. Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;

9. Life expectancy less than 1 year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jingang Zheng

Department of Cardiology, China-Japan Friendship Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Jingang, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Qiang

Role: CONTACT

dawangchen@163.com

+86 13882712184

Facility Contacts

Chen Qiang, MD

Role: primary

dawangchen@163.com

+86 13882712184

Other Identifiers

2024-ZF-13

Identifier Type: -

Identifier Source: org_study_id