Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study
Not Applicable
- Conditions
- ischemic heart disease diabets
- Registration Number
- JPRN-UMIN000027422
- Lead Sponsor
- Division of Cardiology, Nagoya Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with severe ketosis, diabetic coma or precoma 2)Patients with severe infection, perioperative, a severe trauma 3)Patients with moderate renal dysfunction (eGFR: less than 45 ml/min/1.73m2) 4)Patients with severe hepatic dysfunction 5)Patients who are treated with insulin 6)Patients who need treatment with pioglitazone 7)Patients who need treatment with GLP-1RA 8)Patients with a history of hypersensitivity to SGLT-2 inhibitors 9)Women who are or may be pregnant 10)Patients who are treated with PCSK-9 inhibitor 11)Patients who have been determined to be unsuitable for the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Region of interest will be measured by volumetric IVUS at both baseline and 1-year follow-up period. (i) Conventional IVUS: Changes of the percent plaque volume assessed by IVUS. (ii) IB IVUS analysis: Changes of the percent of coronary lipid and fibrous volume assessed by IB-IVUS. The final IVUS exam of PCI is used for IVUS analysis. The target segment is determined in a non-PCI site (> 5 mm proximal or distal to the PCI site), with < 50 % stenosis of the lumen diameter on coronary angiography, in addition to the percentage of plaque area > 20 % at the lumen cross-sectional area. The target segments are assessed at an axial interval of 1 mm for each plaque.
- Secondary Outcome Measures
Name Time Method 1. Ultrasound of cardiography 2. Major adverse cardio-cerebrovascular events 3. Carotid intima-medial thickness 4. BNP 5. HbA1c and FPG 6. Lipid profile 7. General urinary test