Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,600
- Locations
- 1
- Primary Endpoint
- Incidence of Post contrast acute kidney injury (PC-AKI)
Study Overview
Brief Summary
Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).
Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).
Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients receiving invasive treatment
Patients receiving PCI or CAG were enrolled to evaluate the impact of SGLT-2 inhibitors use or not use and duration of SGLT-2 inhibitors administration
Intervention: SGLT-2 inhibitors (Drug)
Outcomes
Primary Outcomes
Incidence of Post contrast acute kidney injury (PC-AKI)
Time Frame: 48 hours after procedure
PC-AKI was defined by the European Society of Genitourinary Radiology (EUSR): increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline
Secondary Outcomes
- All-cause mortality(up to 12 months)
- Major adverse cardiovascular and cerebrovascular events(MACCE)(up to 12 months)
Investigators
Han Yaling
Prof.
Shenyang Northern Hospital