NCT06383208Recruiting
Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics
Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
Source: ClinicalTrials.gov · Last updated 25 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 470 (estimated)
- First submitted
- 21 Apr 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- China-Japan Friendship Hospital
- NCT number
- NCT06383208
What you commit to
- Study type: Observational
- Planned participants: 470
- From 1 Apr 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having undergone kidney transplantation or long-term maintenance dialysis;
- Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;
Other illness
- 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;
- Severe liver disease (Child-Pugh class C);
- Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;
Other
- Pregnancy or lactation;
- Life expectancy less than 1 year.
Who the study is looking for
- 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;
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.