Impact of SGLT2-inhibitors on kidney injury in heart patients
Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy
This study is testing whether a type of diabetes medication can help protect the kidneys of heart patients from injury during certain medical procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shenyang Northern Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06491953 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of SGLT2-inhibitors on post-contrast acute kidney injury (PC-AKI) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). The study aims to determine whether these oral antidiabetic medications can mitigate the risk of kidney injury associated with the use of iodine-based contrast agents during invasive cardiac procedures. By analyzing data from ACS patients, the research seeks to provide insights into the renal protective effects of SGLT2-inhibitors in this specific clinical context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with acute coronary syndrome who are scheduled for invasive treatments like PCI.
Not a fit: Patients with severe renal insufficiency, type 1 diabetes, or contraindications to SGLT2-inhibitors are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney protection strategies for heart patients undergoing invasive procedures.
How similar studies have performed: Previous studies have shown that SGLT2-inhibitors can improve renal function and reduce cardiovascular risks, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ACS patients undergoing invasive treatment (PCI or CAG) * 18 \~ 80 years old adult patients * Written informed consent provided Exclusion Criteria: * Administration of any iodinated CM within 14 days before CAG or PCI * Hepatic dysfunction (ALT 3 times greater than upper normal limit) * Thyreoid insufficiency * Renal artery Stenosis (unilateral \>70％ or bilateral stenosis\>50％) * Known allergy to any of the study drugs or devices (iodinated CM, etc.) * Pregnancy or lactation * Contraindications for the use of SGLT-2 inhibitors, such as severe renal insufficiency (eGFR \<30 mL/min/1.73m2 or currently on dialysis), type 1 diabetes mellitus, severe infection, etc.) * Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators
Where this trial is running
Shenyang, Liaoning
- General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.