MedPath

The Renal Protective Effect Of SGLT2 Inhibitor Drug In Diabetics Patient Who Are Undergoing Per cutaneous Coronary Interventions.

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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>
© Copyright 2025. All Rights Reserved by MedPath