UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048330 |
|---|---|
| Receipt number | R000055085 |
| Scientific Title | Multimodality comparison of intracoronary plaque properties in coronary lesions using near-infrared spectroscopy and ultrasound and coronary computed tomography angiography |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2022/07/09 22:07:20 |
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Basic information
Public title
Multimodality comparison of intracoronary plaque properties in coronary lesions using near-infrared spectroscopy and ultrasound and coronary computed tomography angiography
Acronym
MEASURE trial
Scientific Title
Multimodality comparison of intracoronary plaque properties in coronary lesions using near-infrared spectroscopy and ultrasound and coronary computed tomography angiography
Scientific Title:Acronym
MEASURE trial
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between plaque evaluation by NIRS-IVUS and evaluation by coronary computed tomographic angiography, biomarkers, and functional ischemia evaluation of coronary artery lesions.
Basic objectives2
Others
Basic objectives -Others
Comparison between modalities
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of maxLCBI of NIRS-IVUS and plaque properties obtained by coronary computed tomographic angiography
Key secondary outcomes
-Comparison of maxLCBI with biomarkers and functional ischemia assessment
-Comparison of maxLCBI and peri-coronary inflammation of coronary computed tomographic angiography
-Comparison of peri-coronary inflammation of coronary computed tomographic angiography with biomarkers
-Comparison with plaque properties obtained by coronary computed tomographic angiography with or without oral medication
-Comparison by oral medicine
-Comparison of plaque properties between PCI-adaptive and PCI-non-adaptive blood vessels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with coronary artery disease who have taken 64 or more rows of coronary computed tomographic angiography within 3 months before and after NIRS-IVUS.
Key exclusion criteria
Patients with acute coronary syndrome
Patients with acute decompensated heart failure
Target blood vessels for which PCI has been performed in the past
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-3486
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sunohara |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-3486
Homepage URL
sunoharadaisuke@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Certified Review Board of Clinical Research
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
md_rinri@shinshu-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055085
