UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036721
Receipt No. R000041840
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
Date of disclosure of the study information 2019/05/15
Last modified on 2019/11/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Open public recruiting
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
2019 Year 11 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.