UMIN-CTR Clinical Trial

Basic information
Public title	Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Non-obstructive General Angioscopy and Safety of Angioscopy
Acronym	Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Angioscopy
Scientific Title	Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Non-obstructive General Angioscopy and Safety of Angioscopy
Scientific Title:Acronym	Detecting Spontaneous Ruptured Aortic Plaques and Injuries 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 identify and classify the spontaneous ruptured aortic plaques/injuries by non-obstructive general angioscopy (2015.12-2018.8)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the classification and the incidence of spontaneous ruptured aortic plaques
Key secondary outcomes	change of blood marker and thrombotic symptoms

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	consecutie patients who underwent coronary angioscopy for diagnostic coronary angioscopy or percutaneous coronary intervention.
Key exclusion criteria	acute coronary syndrome, use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability (i.e., Killip state >2 or cardiogenic shock), allergy to contrast media, dialysis, and pregnancy.
Target sample size	880

Research contact person
Name of lead principal investigator	1st name Sei Middle name Last name Komatsu
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovasular Center
Zip code	5540012
Address	5-4-8, Nishi-kujo, Konohana, Osaka
TEL	06-6462-0261
Email	plaquemap@yahoo.co.jp

Public contact
Name of contact person	1st name Sei Middle name Last name Komatsu
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovasular Center
Zip code	5540012
Address	5-4-8, Nishi-kujo, Konohana, 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)

IRB Contact (For public release)
Organization	Research Ethics Committee, Osaka Gyoumeikan Hospital
Address	5-4-8, Nishikujo, Osaka
Tel	0664620261
Email	gyoumeikan_hosp_cardiol@yahoo.co.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	大阪暁明館病院

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 30 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	Completed
Date of protocol fixation	2018 Year 10 Month 31 Day
Date of IRB	2016 Year 07 Month 29 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	to classify spontaenous ruptured aortic plaques and injuries by non-obstructive general angioscopy and the safety of angioscopy

Management information
Registered date	2018 Year 10 Month 31 Day
Last modified on	2020 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039579