UMIN-CTR Clinical Trial

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 NIRS: Association with CCTA
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 NIRS: Association with CCTA
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	Relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary 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	1. At least 18 years of age 2. De novo, native coronary artery lesions 3. Blood cardiac biomarker (Troponin-T) levels less than the local laboratory the upper limit of normal (ULN) before PCI 4. Both NIRS and OCT catheters use are not contra-indicated 5. The lesion received one stent during the initial procedure
Key exclusion criteria	1. Prior coronary revascularization therapy (PCI and/or CABG) to target vessel 2. STEMI within the past 24 hours 3. Simultaneously treated with multi-vesssel PCI on initial procedure 4. LMT case 5. Chronic kidney disease (serum creatinine on admission more than 1.5 mg/dl) 6. Presented with hemodynamic instability (cardiogenic shock) 7. Complex lesion which need to do balloon dilatation (more than 2.0mm balloon or debulking device before pre-procedural NIRS-IVUS 8. Poor image quality case which the technician cannot perform either CTA or NIRS-IVUS measurements 9. Lesions with an EEM diameter <2.0mm
Target sample size	200

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
TEL	058-277-2277
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	500-8384
Address	4-14-4 Yabuta-minami, Gifu-city, Gifu
TEL	058-277-2277
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
Tel	058-277-2277
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 24 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	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 11 Month 08 Day
Anticipated trial start date	2017 Year 01 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	111

Management information
Registered date	2021 Year 01 Month 24 Day
Last modified on	2021 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046006