Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring
- Conditions
- Coronary artery disease in patients with type 2 diabetes mellitusCoronary artery disease, atherosclerosis, type 2 diabetes mellitus, intravascular imaging
- Registration Number
- JPRN-jRCT1052180152
- Lead Sponsor
- Kataoka Yu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1. Male of female between 20 and 80 years of age
2. Type 2 diabetic patients with coronary artery disease
3. Subjects requiring PCI
4. The presence of mild stenosis in the non-target vessel (percent diameter
stenosis between 10-50%) identified by coronary angiography within 12 weeks prior to PCI
5. HbA1c betweeen 7.0% and 10.0%
6. HbA1c less than 10.0% in subjects who receive insulin, sulfonylurea or
nateglinide
7. Ability to understand the requirements of the study and to provide
informed consent
1. very tortuous coronary artery and/or severe calcification which is unsuitable for
intravascular imaging
2. Subjects with severe renal dysfunction (estimated glomerular filtration rate < 40 mL/min/1.73m2)
3. the absence of any atherosclerotic lesions in the non-target vessel
4. those who take PCSK9 inhibitor
5. Pregnancy
6. Current enrolment in another investing device or drug study
7. unsuitable subject according to the investigator's discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change in plaque volume
- Secondary Outcome Measures
Name Time Method Absolute change in percent atheroma volume<br>Absolute change in lipid core burden index<br>the frequency of hypoglycemia