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NCT Number: NCT06491953

SGLT2-inhibitors on PC-AKI

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGLT-2 inhibitors

Drug

SGLT-2 inhibitors use or not use; the duration of SGLT-2 inhibitors use

Primary outcomes

  1. 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

  1. Major adverse cardiovascular and cerebrovascular events(MACCE)

    Time frame: up to 12 months

    Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization

  2. All-cause mortality

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.