Coronary artery disease in patients with type 2 diabetes mellitus Coronary artery disease, atherosclerosis, type 2 diabetes mellitus, intravascular imaging
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in plaque volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in percent atheroma volume Absolute change in lipid core burden index the frequency of hypoglycemia | — |
Contacts
National Cerebral & Cardiovascular Center