Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring

NCT ID: NCT04559191

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-03-31

Brief Summary

The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period.

Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.

Detailed Description

Enrollment of 90 patients is planned at National Cerebral & Cardiovascular Center in Japan. Study participants are randomly assigned to either CGM-based glucose management or HbA1c-based glucose management.

Eligible subjects should have CAD requiring elective PCI. HbA1c at screening should be between 7.0 and 10.0%.

Non-culprit vessel with its severe tortuousty and/or calcification will be excluded. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2 will not be eligible.

After informed consent has been obtained, elective PCI will be conducted to treat culprit lesion. NIRS/IVUS imaging will be conducted to evaluate coronary atheroma.

In the CGM-based glucose management group, CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States) and HbA1c measurement will be undertaken at baseline and 3, 6, 9 and 12 months following PCI. In the HbA1c-based glucose management group, HbA1c will be measured at baseline and 3, 6, 9 and 12 months after PCI, and CGM will be used at baseline and 12 months in a similar fashion..

With regard to the use of anti-diabetic drugs, in the CGM-guided glycemic control group, endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals: (a) the frequency of hypoglycemia=0%, (b) the coefficient of variation <36% and (c) averaged glucose level between 70-180 mg/dl.6 If the frequency of hypoglycemia is over 10% and/or the averaged glucose level is more than 400 mg/dl, patients will be asked to visit within 1 month after CGM measurement. In the HbA1c-guided therapy group, the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c <7.0%.

At 12 months following PCI, patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study. NIRS/IVUS imaging in the non-culprit vessel will be conducted again in a similar fashion.

Conditions

Coronary Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HbA1c-guided group

Glycemic control is controlled by guideline-recommended HbA1c control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CGM-guided group

Glycemic control is controlled by CGM-guided control.

Group Type: ACTIVE_COMPARATOR

continuous glucose monitoring (CGM)

Intervention Type: DEVICE

CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)

Interventions

continuous glucose monitoring (CGM)

CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male of female between 20 and 85 years of age
• Type 2 diabetic patients with coronary artery disease who require PCI
• The presence of mild stenosis in the non-target vessel (% diameter stenosis between 10-50%)
• 7.0 ≤ HbA1c ≤ 10.0%
• HbA1c ≤ 10.0% in subjects who receive insulin, sulfonylurea or nateglinide
• Ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria

• very tortuous coronary artery and/or severe calcification which is unsuitable for intravascular imaging
• Subjects with severe renal dysfunction (estimated glomerular filtration rate < 40 mL/min/1.73m2)
• the absence of any atherosclerotic lesions in the non-target vessel those who take PCSK9 inhibitor
• current enrolment in another investing device or drug study pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role: lead

Responsible Party

Yu Kataoka

Chief consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Kataoka, MD

Role: PRINCIPAL_INVESTIGATOR

National Cerebral & Cardiovascular Center

Locations

National Cerebral & Cardiovascular Center

Suita, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yu Kataoka, MD

Role: CONTACT

yu.kataoka@ncvc.go.jp

+81661701070 ext. 60189

Emi Kanai

Role: CONTACT

kanai.emi@ncvc.go.jp

+81661701070 ext. 40267

Facility Contacts

Yu Kataoka, MD

Role: primary

yu.kataoka@ncvc.go.jp

+81661701070 ext. 60189

References

Kataoka Y, Hosoda K, Makino H, Matsubara M, Matsuo M, Ohata Y, Koezuka R, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Son C, Nishimura K, Asaumi Y, Miyamoto Y, Noguchi T, Yasuda S. The efficacy of glycemic control with continuous glucose monitoring on atheroma progression: rationale and design of the Observation of Coronary Atheroma Progression under Continuous Glucose Monitoring Guidance in Patients with Type 2 Diabetes Mellitus (OPTIMAL). Cardiovasc Diagn Ther. 2019 Oct;9(5):431-438. doi: 10.21037/cdt.2019.09.02.

Reference Type: RESULT

PMID: 31737515 (View on PubMed)

Other Identifiers

M30-152-2

Identifier Type: -

Identifier Source: org_study_id