An observational study in Coronary Artery Disease, Acute Kidney Injury and Contrast-Induced Acute Kidney Injury, sponsored by Collegium Medicum w Bydgoszczy. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Collegium Medicum w Bydgoszczy · Observational
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 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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Collegium Medicum w Bydgoszczy is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Retrospective analysis of data obtained from patients hospitalized between 2020 and 2025 in the Department of Cardiology and Internal Medicine, who underwent coronary angiography or PCI.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who underwent percutaneous coronary procedures while using empagliflozin or dapagliflozin in a standard 10 mg daily dose
Drug: Flozin
Patients who underwent percutaneous coronary interventions but were not using any flozins
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin
Also known as: Empagliflozin, Jardiance, Dapagliflozin, Forxiga
Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)
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
Creatinine change after coronary procedure
Change in serum creatinine concentration before and after the index procedure
Time frame: 0-72 hours
eGFR after coronary procedure
Change in eGFR before and after the index procedure
Time frame: 0-72 hours
Real-life incidence of AKI
the true incidence of CI-AKI in real-world clinical setting
Time frame: 0-72 hours
incidence of CI-AKI in diabetic patients
the effect of SGLTi on the occurrence of CI-AKI in patients with and without type 2 diabetes mellitus
Time frame: 0-72 hours
incidence of CI-AKI in ACS patients using flozins
the effect of SGLTi on the occurrence of CI-AKI in patients with and without acute coronary syndrome
Time frame: 0-72 hours
incidence of CI-AKI on empagliflozin vs dapagliflozin
the effects of dapagliflozin versus empagliflozin on the occurrence of CI-AKI in the overall study population
Time frame: 0-72 hours
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2025, 1 month after the start.
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Collegium Medicum w Bydgoszczy