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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042883
Receipt No. R000048945
Scientific Title Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Date of disclosure of the study information 2021/01/01
Last modified on 2021/01/01

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Basic information
Public title Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Acronym Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Scientific Title Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Scientific Title:Acronym Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Region
Japan

Condition
Condition Ischemic Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary lesions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and coronary plaque characteristics by CCTA in the same lesions
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were suspected of having coronary artery disease by 64-slice MDCT before percutaneous coronary intervention (PCI) at our institution
Key exclusion criteria 1. Chronic kidney disease manifested by an estimated glomerular filtration rate of < 40 mL/min/1.73 m2
2. Significant left main disease
3. Previously stented lesions. In addition, patients with extensively severe stenotic lesions which was anticipated difficulty in advancing the NIRS-IVUS catheter without plain old balloon angioplasty (POBA) using more than 2.0 mm of diameter were excluded.
4. Extremely calcified lesions treated with atheroablative device (e.g. Rotablator and Diamondback 360).
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Matsuo
Organization Gifu Heart Center
Division name Department of Cardiology
Zip code 500-8384
Address 4-14-4 Yabuta-minami, Gifu-city, Gifu, 500-8384, JAPAN
TEL +81-58-277-2277
Email matsuo@heart-center.or.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Ota
Organization Gifu Heart Center
Division name Department of Cardiology
Zip code 5008384
Address 4-14-4 Yabuta-minami, Gifu-city, Gifu, 500-8384, JAPAN
TEL +81-58-277-2277
Homepage URL
Email ota@heart-center.or.jp

Sponsor
Institute Gifu Heart Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board, Gifu Heart Center
Address 4-14-4 Yabuta-minami, Gifu-city, Gifu, 500-8384, JAPAN
Tel +81582772277
Email ota@heart-center.or.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
2021 Year 01 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 20 Day
Date of IRB
2017 Year 05 Month 25 Day
Anticipated trial start date
2017 Year 06 Month 01 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 The relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and coronary plaque characteristics by CCTA in the same lesions

Management information
Registered date
2021 Year 01 Month 01 Day
Last modified on
2021 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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