UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Prospective Registry of Patients with Coronary Artery Disease Who Underwent Percutaneous Coronary Intervention Using Near Infrared Spectroscopy-Intravascular Ultrasound Imaging
Title of the study (Brief title)	Chiba NIRS-IVUS Registry
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate lipid rich plaque using near infrared spectroscopy-intravascular ultrasound imaging, and clarify the relationship between lipid rich plaque and acute procedural results of percutaneous coronary intervention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Relationship between lipid rich plaques detected by NIRS-IVUS and patients or lesion characteristics 2)Relationship between lipid rich plaques detected by NIRS-IVUS and acute procedural results of percutaneous coronary intervention
Key secondary outcomes	Two-year clinical outcomes associated with lipid rich plaques detected by NIRS-IVUS, including cardiac death, cardiac arrest, myocardial infarction, acute coronary syndrome, revascularization, rehospitalization for progressiove angine

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	NIRS-IVUS
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent percutaneous coronary intervention using NIRS-IVUS
Key exclusion criteria	Pregnancy
Target sample size	300

Research contact person
Name of lead principal investigator	Yoshio Kobayashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 2608677 JAPAN
TEL	+81-43-226-2340
Email	yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person	Tadayuki Kadohira
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 2608677 JAPAN
TEL	+81-43-226-2340
Homepage URL
Email	t-kadohira@mua.biglobe.ne.jp

Sponsor
Institute	Chiba University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Chiba University Graduate School of Medicine, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 23 Day
Anticipated trial start date	2017 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 05 Day
Last modified on	2017 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031665