UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036721 |
|---|---|
| Receipt number | 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 | 2022/05/14 09:37:09 |
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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
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
yu.kataoka@ncvc.go.jp
Sponsor or person
Institute
National Cerebral & Cardiovascular Centre
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041840
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| Registered date | File name |
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