UMIN-CTR Clinical Trial

Basic information
Public title	Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy Having or Suspected coronary Artery Disease
Acronym	Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy
Scientific Title	Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy Having or Suspected coronary Artery Disease
Scientific Title:Acronym	Detecting Vessel Abnormality by Non-Obstructive General Angioscopy
Region	Japan

Condition
Condition	Vessel abnormality (Aorta, venous system)
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To detect vessel abnormality such as aortic plaques and injuries, to evaluate the incidence and character and examine the relationship between aortic, coronary , and embolic disease
Basic objectives2	Others
Basic objectives -Others	observational, cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	embolic disease and rupturing aortic disease
Key secondary outcomes	The incidence of location, the inflammatory level, and the degree of plaques by non-obstructive general angioscopy, heart failure

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	patients who undergo cardiovascular catheter such as coronary artery, aorta and vein
Key exclusion criteria	cardiogenic shock without hemodynamic support, aortic disease which needed emergent operation, allergy to contrast media, and pregnancy
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Sei Middle name Last name Komatsu
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovascular Center
Zip code	5540012
Address	5-4-8, Nishikujo, Konohana, Japan
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	Cardiovascular Center
Zip code	554-0012
Address	5-4-8, nishi-kujo, Konohana, Osaka
TEL	06-6462-0261
Homepage URL
Email	plaquemap@yahoo.co.jp

Sponsor
Institute	Cardiovascular Center, 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	Osaka Gyoumeikan Hospital
Address	5-4-8, Nishikujo, Osaka
Tel	06-6462-0261
Email	plaquemap@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（大阪府）

Other administrative information
Date of disclosure of the study information	2022 Year 10 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	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 26 Day
Date of IRB	2017 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Characteristics of Vessels such as aortic and coronary injuries and venous system are compared among biomarkers, pathological ways and clinical characteristics.

Management information
Registered date	2020 Year 10 Month 20 Day
Last modified on	2020 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048145