UMIN-CTR Clinical Trial

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
Email	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
Email	sunoharadaisuke@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055085