Biomarkers to predict CSA-AKI risk before heart surgery
Official title: Early Prediction and Diagnosis of CSA-AKI
Run by China National Center for Cardiovascular Diseases · NCT07811570 · Data updated 2026-11-12
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07811570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older scheduled for cardiovascular surgery who have baseline kidney function within listed creatinine criteria and provide informed consent.
✕Probably not a fit
Patients with preexisting severe kidney disease requiring dialysis or other exclusion criteria may not benefit from this biomarker approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses nested case-control analyses within prospective cohorts of adults scheduled for cardiovascular surgery. It collects blood, urine, stool samples and clinical data before and after contrast exposure and around the surgical procedure, tracking CSA-AKI occurrence and outcomes over time. Biomarkers are discovered and validated with multi-omics and machine learning approaches to see if they can predict CSA-AKI before it develops. The study aims to identify reliable biomarker signatures that improve early risk stratification in this patient group.
Why it matters
Potential benefit: If successful, the biomarkers could enable earlier risk stratification and targeted preventive strategies for CSA-AKI in patients undergoing cardiovascular surgery.
How similar studies have gone: Previous studies have shown promise for multi-omics biomarkers in AKI risk, but this project aims to validate and refine them specifically for CSA-AKI in the surgical setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age no less than 18 years old; * 2\. Scheduled cardiovascular surgery is proposed; * 3\. Pre-angiography and preoperative serum creatinine \<354 μ mol/L; * 4\. Informed consent. Exclusion Criteria: * 1\. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding; * 2\. Patients who have severe side effects such as allergies to iodine contrast agents; * 3\. Patients with hyperthyroidism; * 4\. Those who had AKI before the contrast agent or within 2 weeks before the operation, or whose AKI has not been relieved after the operation; * 5\. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment; * 6\. Patients with malignant tumors or those with an expected lifespan of less than 12 months; * 7\. Angiography or preoperative acute heart failure; * 8\. Patients who have a history of massive hemorrhage in the past 30 days or have contraindications to anticoagulant therapy.
Where it's running
-
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jianfang Cai
- Email: caijfbj@126.com
- Phone: +86 15801601007
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.