UMIN-CTR Clinical Trial

Basic information
Public title	Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-infrared Spectroscopic Analaysis
Acronym	OPTIMAL
Scientific Title	Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-infrared Spectroscopic Analaysis
Scientific Title:Acronym	OPTIMAL
Region	Japan

Condition
Condition	Coronary artery disease requiring percutaneous coronary intervention
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	the absolute change in percent atheroma volume
Key secondary outcomes	change in percent atheroma volume the percent change in lipid core burden index the frequency of hypoglycemia

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	CGM-guided glycemic control
Interventions/Control_2	HbA1c-guided glycemic control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Eligible subjects should have CAD requiring elective PCI. Mild stenosis needs to exist within non-culprit major coronary artery. Since the current study enroll subjects who need glucose lowering therapy to achieve HbA1c (NGSP/IFCC) < 7.0%/53 mmol/mol, HbA1c (NGSP/IFCC) at screening should be between 7.0/53 and 10.0%/86 mmol/mol. In T2DM subjects who already receive sulphonylurea, nateglinide and/or insulin at screening, baseline HbA1c (NGSP/IFCC) should be below 10.0%/86 mmol/mol and the lowest cut-off is not set. Due to an elevated risk of hypoglycemia under these anti-diabetic agents, subjects with HbA1c (NGSP/IFCC) <7.0%/53 mmol/mol may have hypoglycemic events which require adequate glycemic control.
Key exclusion criteria	The main exclusion criteria are listed in Table 3. Non-culprit vessel with its severe tortuousty and/or calcification will be excluded due to the risk of NIRS/IVUS imaging. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2, those without any atherosclerotic lesions in their non-culprit vessels and patients who are taking or are scheduled to receive proprotein convertase subxilisin/kexin type 9 will not be eligible.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Kataoka
Organization	National Cerebral & Cardiovascular Centre
Division name	Department of Cardiovascular Medicine
Zip code	5658565
Address	Fujishirodai 5-7-1, Suita, Osaka, Japan
TEL	06-6833-5012
Email	yu.kataoka@ncvc.go.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Kataoka
Organization	National Cerebral & Cardiovascular Center
Division name	Department of Cardiovascular Medicine
Zip code	5658565
Address	Fujishirodai 5-7-1, Suita, Osaka, Japan
TEL	06-6833-5012
Homepage URL
Email	yu.kataoka@ncvc.go.jp

Sponsor
Institute	National Cerebral & Cardiovascular Centre
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cerebral & Cardiovascular Center reserach ethics committee
Address	5-7-1 Fujishirodai, SUita, Osaka, Japan
Tel	06-6833-5012
Email	rec-office-ac@ncvc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立循環器病研究センター

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	94
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 11 Month 05 Day
Date of IRB	2018 Year 12 Month 26 Day
Anticipated trial start date	2019 Year 03 Month 06 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041840