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

NCT06383208 | Recruiting

• 1 other identifier: 2024-ZF-13
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Kidney Diseases; Coronary Heart Disease; Lipid Metabolism Disorders; Cardiovascular-Renal adverse prognosis; Metabolomics

Outcome Measures

Primary Outcomes (2)

• 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;

  12 month follow-up

• 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.

  12 month follow-up

Secondary Outcomes (3)

• Incidence of All-cause mortality

  12 month follow-up

• Incidence of Repeat revascularization

  12 month follow-up

• Incidence of bleeding

  12 month follow-up

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.;
• 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;

You may not qualify if:

• 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;
• Having undergone kidney transplantation or long-term maintenance dialysis;
• Severe liver disease (Child-Pugh class C);
• Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;
• Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;
• Life expectancy less than 1 year.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect 4 ml of fasting peripheral venous blood from enrolled patients. Fasting should commence at 22:00 the day before blood collection. The blood should be placed in EDTA anticoagulant tubes. Within 2 hours after blood collection, plasma should be separated and stored for subsequent lipidomic analysis. This involves centrifuging at 3000 rpm for 10 minutes to separate the plasma. Transfer the upper layer of plasma into 200 ul/1.5 ml EP tubes, then store at -80°C for preservation.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Coronary Disease; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zheng Jingang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Qiang

CONTACT

+86 13882712184; dawangchen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cardiology, China-Japan Friendship Hospital

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)