The Renal Protective Effect Of SGLT2 Inhibitor Drug In Diabetics Patient Who Are Undergoing Per cutaneous Coronary Interventions.
- Conditions
- Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
- Registration Number
- CTRI/2023/10/058896
- Lead Sponsor
- GSM Institute of Pharmaceutical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Age - >18 years
Medication duration 3months - 3years
T2DM with indication of PCI
Obstructive coronary artery disease, characterized by a =50% narrowing in a major epicardial vessel, and who also have a clinical indication for undergoing PCI.
Willing to provide consent to participate in the study
eGFR range 50-90 ml/min/1.73m2
Auto immune disease
Chronic use of anti-inflammatory medications.
Severe anemia
Dialysis
Cardiogenic shock
Use of nephrotoxic drugs
History of CIN
Use of contrast media less than 7 days
Pregnant
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum creatinine values <br/ ><br>BUN <br/ ><br>eGFR <br/ ><br>Requirement of Dialysis <br/ ><br>Micro/macroalbuminuria <br/ ><br>CI-AKI <br/ ><br>Requirement of dialysis <br/ ><br>Timepoint: At Baseline and 48 hours and 30 to 37 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method At Baseline, biomarkers elevation of creatine kinase MB CKMB less than or equal to 10 times the upper reference limit URL and troponin less than or equal to 70 times the upper reference limit URL within 24 hours after PCI. <br/ ><br>ECG Echo <br/ ><br>ADRs during the study period. <br/ ><br>Occurrence of definite or probable stent thrombosis Until 30 days <br/ ><br>Death from CVD cause, MI, Stroke Bleeding Until 30 days. <br/ ><br>Complete Blood Count <br/ ><br>LVEF <br/ ><br>Timepoint: At Baseline and 48 hours and 30 to 37 days <br/ ><br>