Collegium Medicum w Bydgoszczy
Bydgoszcz, 85-094, Poland
Location status: Recruiting
NCT Number: NCT07231939
All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion.
The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.
The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.
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Request Info18 year and older
All sexes
Observational
Bydgoszcz, 85-094, Poland
Location status: Recruiting
The use of radiological imaging methods requiring iodine-based contrast media (ICM) has been steadily increasing in recent years. Contrast-induced acute kidney injury (CI-AKI), formerly referred to as contrast-induced nephropathy (CIN), is one of the most common causes of acute kidney injury in patients undergoing diagnostic or therapeutic procedures involving ICM.
The study was designed as a retrospective, single-centre, cross-sectional, cohort, case-control study. All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion. The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.
The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.
The analysis of the baseline characteristics of the study population is planned.
Based on the results of the study, a meta-analysis combining the results of previously published studies with those of the present study will be performed.
Key variables to be analyzed: type and volume of ICM; serum creatinine concentration at baseline, 24 h, 48 h, and 72 h after the procedure; eGFR at baseline, 24 h, 48 h, and 72 h; use of SGLT2i within 3 days prior to the procedure; long-term use of SGLT2i; type of SGLT2i administered.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin
Other names: Empagliflozin, Jardiance, Dapagliflozin, Forxiga
Time frame: 0-72 hours
Occurrence of CI-AKI defined as an increase in serum creatinine concentration of ≥0.5 mg/dL (44.2 μmol/L) or >25% compared with baseline within 72 h after intravascular administration a contrast medium agent
Time frame: 0-72 hours
Change in serum creatinine concentration before and after the index procedure
Time frame: 0-72 hours
Change in eGFR before and after the index procedure
Time frame: 0-72 hours
the true incidence of CI-AKI in real-world clinical setting
Time frame: 0-72 hours
the effect of SGLTi on the occurrence of CI-AKI in patients with and without type 2 diabetes mellitus
Time frame: 0-72 hours
the effect of SGLTi on the occurrence of CI-AKI in patients with and without acute coronary syndrome
Time frame: 0-72 hours
the effects of dapagliflozin versus empagliflozin on the occurrence of CI-AKI in the overall study population
Contact information is provided by the study sponsor or research team.
Collegium Medicum w Bydgoszczy
Other
FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study
Acronym: FLORENCE
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.
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