Skip to content

Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052180152
Enrollment
90
Registered
2019-03-25
Start date
2019-03-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease in patients with type 2 diabetes mellitus Coronary artery disease, atherosclerosis, type 2 diabetes mellitus, intravascular imaging

Interventions

A. glycemic management under CGM use B. glycemic management under HbA1c measurement

Sponsors

Kataoka Yu
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Absolute change in plaque volume

Secondary

MeasureTime frame
Absolute change in percent atheroma volume Absolute change in lipid core burden index the frequency of hypoglycemia

Contacts

Public ContactYu Kataoka

National Cerebral & Cardiovascular Center

yu.kataoka@ncvc.go.jp+81-6-6833-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026