UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detecting Ruptured Aortic Plaques by Non-obstructive angioscopy
Title of the study (Brief title)	Detecting Ruptured Aortic Plaques by angioscopy
Region	Japan

Condition
Condition	coronary heart disease or suspected
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the ruptured aortic plaques by non-obstructive angioscopy (2015.10-2017.9)
Basic objectives2	Others
Basic objectives -Others	cross-sectional, observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence and pathologic classification of ruptured aortic plaque
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	consecutive patients who underwent coronary angioscopy for diagnosic coronary angioscopy or percutaneous coronary intervention.
Key exclusion criteria	acute coronary syndrome, use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability, aortic dissection, aortic aneurysm larger than the size indicated for surgery, allergy to contrast media, and pregnancy.
Target sample size	324

Research contact person
Name of lead principal investigator	Sei Komatsu, MD, PhD
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovascular Center
Address	5-4-8, Nishi-Kujo, Konohana, Osaka
TEL	06-6462-0261
Email	plaquemap@yahoo.co.jp

Public contact
Name of contact person	Sei Komatsu, MD, PhD
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovascular Center
Address	5-4-8, Nishi-Kujo, Konohana, 554-0012, Osaka
TEL	06-6462-0261
Homepage URL
Email	plaquemap@yahoo.co.jp

Sponsor
Institute	Osaka Gyoumeikan Hospital
Institute
Department

Funding Source
Organization	Osaka Gyoumeikan Hospital
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	大阪暁明館病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 10 Month 31 Day
Last follow-up date	2017 Year 11 Month 19 Day
Date of closure to data entry	2017 Year 11 Month 19 Day
Date trial data considered complete	2017 Year 11 Month 19 Day
Date analysis concluded	2017 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The sizes of aortic plaque rupture were smaller than thought.
Other related information	to identify the incidence of aortic plaque rupture, and to measure the sizes of aortic plaque rupture by direct sampling using non-obstructive angioscopy system

Management information
Registered date	2017 Year 10 Month 31 Day
Last modified on	2017 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034016