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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChina-Japan Friendship Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 18-80 years old;

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;

Patients with clarified renal function status.;

Disqualifiers

Pregnancy or lactation;

Severe valve disease or severe mechanical complications requiring surgical intervention;

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

Severe hematologic disorders or end-stage malignant tumors;

Trial population

The population of this study will be selected from China-Japan Friendship Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • lipid metabolomics

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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. 1. 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. 2. 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. 3. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG;

Time frame
12 month follow-up
2

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). 1. Renal failure: End-stage kidney disease (ESKD) or eGFR persistently below 15 ml/min/1.73 m². 2. 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. 3. 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.

Time frame
12 month follow-up

Secondary outcomes

1

Incidence of All-cause mortality

All-cause deaths includes cardiac death, vascular death and non-cardiovascular death. 1. 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. 2. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 3. 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

Time frame
12 month follow-up
2

Incidence of Repeat revascularization

Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.

Time frame
12 month follow-up
3

Incidence of bleeding

Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.

Time frame
12 month follow-up

Other outcomes

Sponsors and contacts

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