JPRN-jRCT1052180152
Recruiting
Phase 4
Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-InfRared Spectroscopic Analysis - OPTIMAL-NIRS study
Kataoka Yu0 sites90 target enrollmentMarch 25, 2019
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary artery disease in patients with type 2 diabetes mellitus
- Sponsor
- Kataoka Yu
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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