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

Chronic Kidney Diseases Clinical Trial

— CRUISE-MET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383208
• Other study ID #: 2024-ZF-13
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: China-Japan Friendship Hospital
• Contact: Chen Qiang
• Phone: +86 13882712184
• Email: dawangchen[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Kidney Diseases
• Lipid Metabolism Disorders
• Metabolic Diseases
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular adverse events	Cardiovascular adverse events includes Cardiovascular-related death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, rehospitalization for heart failure.; Cardiovascular events related to mortality: This includes 1) cardiovascular death; 2) death caused by stroke; 3) death resulting from cardiovascular surgery; 4) death from other cardiovascular causes.; Cardiovascular death: During the follow-up period, this refers to death directly associated with documented myocardial infarction, heart failure, or arrhythmia. It also includes death events where the cause is unclear and not attributed to any other underlying conditions.; Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG;	12 month follow-up
Primary	Incidence of Renal composite endpoint event	Renal composite endpoint event includes renal failure, renal-related death, or a decrease in eGFR >40% from baseline (confirmed by a second test 4 weeks later).; Renal failure: End-stage kidney disease (ESKD) or eGFR persistently below 15 ml/min/1.73 m².; End-stage kidney disease: Receiving renal replacement therapy (RRT), including hemodialysis/peritoneal dialysis, for more than 3 months, or undergoing kidney transplantation. Acute kidney injury (AKI) events leading to dialysis and death are also considered end-stage kidney disease (ESKD) events.; Renal-related death: Meeting both of the following criteria: 1) The patient died during the follow-up period; 2) Despite the need for renal replacement therapy (RRT) due to their condition, it was not received;3)No other clear cause of death.	12 month follow-up
Secondary	Incidence of All-cause mortality	All-cause deaths includes cardiac death, vascular death and non-cardiovascular death.; Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.; Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases.; Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma	12 month follow-up
Secondary	Incidence of Repeat revascularization	Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.	12 month follow-up
Secondary	Incidence of bleeding	Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.	12 month follow-up