UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy in Patients with COronary Heart Disease
Title of the study (Brief title)	Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy
Region	Japan

Condition
Condition	Coronary heart disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To detect the incidence of aortic plaque, to detect the variety of aortic plaque, and examine the relationship between aortic and coronary plaque
Basic objectives2	Others
Basic objectives -Others	observational, cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	acute aortic syndrome and atheromatous embolization
Key secondary outcomes	The incidence, location, and the degree of ruptured aortic plaques detected by non-obstructive angioscopy

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who underwent diagnostic coronary angiography (CAG) or elective percutaneous coronary intervention (PCI) with non-obstructive angioscopy
Key exclusion criteria	use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability (i.e., Killip state >2 or cardiogenic shock), known aortic dissection, aortic aneurysm larger than the size indicated for surgery, (thoracic diameter >=6 mm or abdominal diameter >=5 mm), allergy to contrast media, and pregnancy.
Target sample size	1500

Research contact person
Name of lead principal investigator	Kauzhisa Kodama, MD, PhD
Organization	Osaka Gyoumeikan Hospital
Division name	Cardiovascular Center
Address	5-4-8, Nishi-Kujo, Konohana, Osaka
TEL	06-6462-0261
Email	ascopy_kdm@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	Cardiovascular Center, Osaka Gyoumeikan Hospital
Institute
Department

Funding Source
Organization	Cardiovascular Center, 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	2022 Year 04 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 05 Month 01 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	To identify the incidence of spontaneous aortic plaque rupture, the components of spontaneous aortic plaque rupture and the dimension and pathologic findings of each component by direct sampling using NOA system. To analyze the relationship between the details of aortic plaque rupture and patients' characteristics, CT findings, MRI findings, echo findings, and coronary plaque detected by intravascular ultrasound, OCT, and angioscopy and pathological findings.

Management information
Registered date	2017 Year 10 Month 28 Day
Last modified on	2017 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033981