Clinical trial NCT06383208: Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics
Official title: Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Coronary Heart Disease
Lipid Metabolism Disorders
Keywords: Chronic Kidney Diseases
Coronary Heart Disease
Lipid Metabolism Disorders
Cardiovascular-Renal adverse prognosis
Metabolomics
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study will be selected from China-Japan Friendship Hospital

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.


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.

Primary outcomes:
measure: Incidence of cardiovascular adverse events
timeFrame: 12 month follow-up
measure: Incidence of Renal composite endpoint event
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Incidence of All-cause mortality
timeFrame: 12 month follow-up
measure: Incidence of Repeat revascularization
timeFrame: 12 month follow-up
measure: Incidence of bleeding
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Zheng Jingang, MD
role: PRINCIPAL_INVESTIGATOR
References: