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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035014
Receipt No. R000039916
Scientific Title Evaluation of AtheroSclerotic and rupture evenTs by Non-obstructive general angioscopy
Date of disclosure of the study information 2018/11/29
Last modified on 2018/11/26

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Basic information
Public title Evaluation of AtheroSclerotic and rupture evenTs by Non-obstructive general angioscopy
Acronym EAST-NOGA study
Scientific Title Evaluation of AtheroSclerotic and rupture evenTs by Non-obstructive general angioscopy
Scientific Title:Acronym EAST-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 frequency and quality of aortic plaques with non-obstructive general angioscopy and the frequency of occurrence of angioscopy-related complications.
Basic objectives2 Others
Basic objectives -Others Multicenter, prospective, observational registory
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.the frequency and quality of aortic plaques
2.the frequency of occurrence of complication with angioscopy between during observation of the aorta and after 48 hours
Key secondary outcomes 1.the relationship between the aortic plaques findings with angioscopy and CT
2.the relationship between the aortic plaques findings with angioscopy and pathology
3.the relationship between the aortic plaques and the coronary plaques with angioscopy
4.the changes of aortic plaque findings with angioscopy
5.the relationship between aortic plaque findings with angioscopy and atherosclerotic risk factors
6.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
85 years-old >
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 angioscopy for the aorta
3) written informed consent
Key exclusion criteria 1) acute aortic dissection or rupture of aortic aneurysm, or impending state of them
2) occurrence of aortic dissection within one month
3) aortic aneurysm larger than the size indicated for surgery
4) cardiogenic shock
5) occurrence of aortic dissection within 72 hours
6) stroke on acute phase
7) hypertension with poor control
8) severe renal dysfunction (Cre >=2.5 mg or eGFR =<15 ml/min/1.73m2)
9) anaphylactic shock by contrast medium
10)pregnancy or breast-feeding
11) appropriate patients decided by the doctor
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Kodama
Organization Osaka Police hospital
Division name cardiology
Zip code
Address 10-31 Kitayama-cho, Tenoji-ku, Osaka city
TEL 06-6771-6051
Email ascopy_kdm@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hirayama, MD, PhD
Organization Nihon University School of Medicine
Division name Division of Cardiology, Department of Medicine
Zip code
Address 30-1 Ohyaguchi-kamicho, itabashiku, Tokyo
TEL 03-3972-8111
Homepage URL
Email hirayama.atsushi@nihon-u.ac.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
Address
Tel
Email

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 29 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 No longer recruiting
Date of protocol fixation
2014 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 14 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To clarify the frequency and quality of aortic plaques with NOGA

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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