Clinical trial NCT06491953: SGLT2-inhibitors on PC-AKI
Official title: Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACS patients aged 18-80 years old receiving invasive treatment were enrolled.

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.


Eligibility 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

Primary outcomes:
measure: Incidence of Post contrast acute kidney injury (PC-AKI)
timeFrame: 48 hours after procedure
Secondary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events(MACCE)
timeFrame: up to 12 months
measure: All-cause mortality
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
References: