Effect of dapagliflozin on Periprocedural Myocardial Injury and contrast-induced acute kidney injury
- Conditions
- Periprocedural myocardial injury or infarction and acute kidney injury in patients with coronary artery disease with or without chronic kidney disease undergoing coronary angiography with possible percutaneous coronary interventionCoronary artery disease, chronic kidney disease, coronary angiography, percutaneoua coronary intervention, periprocedural myocardial injury, periprocedural myocardial infarction, acute kidney injury.
- Registration Number
- TCTR20230109004
- Lead Sponsor
- ational Science, Research and Innovation Fund (NSRF)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 292
1.Adult (age 18-75 years old) undergoing elective CAG with possible PCI or elective staged PCI
2.Diagnosed with chronic coronary syndrome or stable acute coronary syndrome (including unstable angina, non-ST segment elevation myocardial infarction, defined as normal or stable elevated or falling high sensitivity troponin before procedure)
3.Estimated glomerular filtration rate more than 30 mL/min/1.73m2 (CKD-EPI formula)
1.Decline for study participation or not provide informed consent
2.Blood sugar at screening morethan 300 mg/dL
3.Rise in serum creatinine of more than 50 percentage from the baseline value or presumed to have occurred within 7 days.
4.History of allergy to any SGLT2 inhibitor
5.Past or current treatment with any SGLT2 inhibitor
6.History of type 1 diabetes mellitus
7.Current use of insulin
8.Previous history of diabetic ketoacidosis
9.Current treatment with loop diuretic
10.History of any genital infection
11.History of urinary tract infection within 3 months
12.Currently receiving long term (>30 consecutive days) treatment with an oral steroid, immunosuppressive drug
13.Pregnant woman or during lactation period
14.Patients whom their comorbidities, judged by study researcher, may limit the study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary cardiac outcome: Composite of PCI-related MI (type 4a or 4b, see the definitions below) or major myocardial injury within 48 hours after PCI within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Primary kidney outcome: Acute kidney injury defined by 10% increase of serum cystatin C after CAG or PCI compared with baseline value within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software
- Secondary Outcome Measures
Name Time Method