UMIN-CTR Clinical Trial

Basic information
Public title	Detection of Ruptured plaques as Embolic source in Aorta to clarify the Mechanism of systemic organ deterioration by Non-Obstructive General Angioscopy
Acronym	Relationship between aortic plaques and organ insufficiency: DREAM NOGA study
Scientific Title	Detection of Ruptured plaques as Embolic source in Aorta to clarify the Mechanism of systemic organ deterioration by Non-Obstructive General Angioscopy
Scientific Title:Acronym	Relationship between aortic plaques and organ insufficiency: DREAM NOGA study
Region	Japan

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

Objectives
Narrative objectives1	To clarify the relationship between the frequency and quality of aortic plaques with non-obstructive general angioscopy and organ insufficiency such as brain, kidney, and peripheral artery.
Basic objectives2	Others
Basic objectives -Others	Multicenter, prospective, observational registory
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.the relationship between the quality of aortic plaques and the increase of cerebral infarction with MRI 2.the relationship between the quality of aortic plaques and the increase of urinary albumin creatinin ratio 3.the relationship between the quality of aortic plaques and the change of ABI value and sarcopenia score 4.the relationship between aortic plaques and the occurrence of acute aortic dissection
Key secondary outcomes	1.the relationship between the frequency of aortic plaques and the increase of cerebral infarction with MRI 2.the relationship between the frequency of aortic plaques and the increase of urinary albumin creatinin ratio 3.the relationship between the frequency of aortic plaques and the change of ABI value 4.comparison of aortic plaque findings between non-obstructive general angioscopy and aortic CT 5.the comparison between coronary and aortic plaque findings with non-obstructive general angioscopy 6.the progression of aortic plaques 7.the relationship between aortic plaque and influence factors 8.the relationship between aortic plaque and brain atrophy with MRI 9.the relationship between aortic plaque and atherosclerosis with brain MRI 10.the relationship between aortic plaque and dementia score 11.the relationship between aortic plaque and carotid duplex ultrasound findings 12.the relationship between aortic plaque and SPP score 13.the relationship between aortic plaque and sarcopenia score 14.the frequency of occurrence of complication with non-obstructive general angioscopy during and 48 hours after the procedure 15.the relationships aortic plaques and clinical events

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	1) patient who received CAG or PCI with confirmed or suspected of cardiovascular disease underwent 2) patient who received non-obstructive general angioscopy 3) Patients who clinically have high risk of occurrence of aortic disease and aortic CT examination is useful for patients 4) Patients who clinically have high risk of occurrence of cerebral infarction and brain MRI is useful for patients high risk of occurrence of cerebral infarction was defined as 1) neurological symptom, 2)atherosclerotic factors, and aortic calcification with Xray or CT 5) >= 20 years old, male and female 6) written informed consent
Key exclusion criteria	1) anaphylactic shock by contrast medium 2) metal in the body 3) Claustrophobia 4) pregnancy or breast-feeding 5) cardiogenic shock 6) acute aortic dissection or rupture of aortic aneurysm, or impending state of them 7) appropriate patients decided by the doctor
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Hirayama
Organization	Nihon University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Zip code	173-8610
Address	30-1 Ohyaguchi-kamicho, itabashi-ku, Tokyo
TEL	03-3972-8111
Email	atsushi-hirayama@oph.gr.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Hirayama
Organization	Nihon University School of Medicine, Division of Cardiology
Division name	Division of Cardiology, Department of Medicine
Zip code	173-8610
Address	30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	atsushi-hirayama@oph.gr.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nihon University Itabashi Hospital Clinical Research Center
Address	30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
Tel	03-3972-8111
Email	med.itabashi.chiken@nihon-u.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 01 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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date	2018 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Relationship between aortic plaques with non-obstructive general angioscopy and organ insufficiency

Management information
Registered date	2018 Year 10 Month 22 Day
Last modified on	2021 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039419