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

Last updated: April 21, 2024
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Heart Attack (Myocardial Infarction)

Hypercholesterolemia

Treatment

lipid metabolomics

Clinical Study ID

NCT06383208
2024-ZF-13
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years old;
  2. Diagnosed with CHD during hospitalization through coronary angiography, includingST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation acutecoronary 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 3months: eGFR < 60 ml/min/1.73 m² or eGFR ≥ 60 ml/min/1.73 m² and urinaryalbumin-to-creatinine ratio (uACR) ≥ 30 mg/g;

Exclusion

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. Severe valve disease or severe mechanical complications requiring surgicalintervention;
  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 forenrollment;
  8. Severe chronic lung disease requiring long-term mechanical ventilation support orawaiting lung transplantation;
  9. Life expectancy less than 1 year.

Study Design

Total Participants: 470
Treatment Group(s): 1
Primary Treatment: lipid metabolomics
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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