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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036564
Receipt No. R000041659
Scientific Title SponTaneously Ruptured aOrtic plaques as a potential cause of embolic stroKEs visualized by Non-Obstructive General Angioscopy
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/21

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Basic information
Public title SponTaneously Ruptured aOrtic plaques as a potential cause of embolic stroKEs visualized by Non-Obstructive General Angioscopy
Acronym Relationship between aortic plaques and ischemic stroke: STROKE NOGA study
Scientific Title SponTaneously Ruptured aOrtic plaques as a potential cause of embolic stroKEs visualized by Non-Obstructive General Angioscopy
Scientific Title:Acronym Relationship between aortic plaques and ischemic stroke: STROKE 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 ischemic strokes.
Basic objectives2 Others
Basic objectives -Others Singlecenter, prospective, observational registry
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ralationship between the frequecy and quality of aortic plaques and the increase of ischemic strokes.
Key secondary outcomes The relationship between aortic plaques and carotid dulpex ultrasound findings

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 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 cerebral infarction and brain MRI is useful for patients
4) >= 20 years old, male and female
5) written informed consent
Key exclusion criteria 1)inappropriate patients for MRI
2)physician's decision of ineligibility for entry
Target sample size 200

Research contact person
Name of lead principal investigator
1st name HIGUCHI
Middle name
Last name YOSHIHARU
Organization Osaka Police Hospital
Division name Division of Cardiology
Zip code 543-0035
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka City
TEL 06-6771-6051
Email yhiguchi-ja@umin.net

Public contact
Name of contact person
1st name HIGUCHI
Middle name
Last name YOSHIHARU
Organization Osaka Police Hospital
Division name Division of Cardiology
Zip code 543-0035
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka City
TEL 06-6771-6051
Homepage URL
Email yhiguchi-ja@umin.net

Sponsor
Institute Osaka Police Hospital
Institute
Department

Funding Source
Organization Osaka Police 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 Police Hospital Ethical Committee
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka City
Tel 06-6771-6051
Email soumu@oph.gr.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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Singlecenter, prospective, observational registry

Management information
Registered date
2019 Year 04 Month 21 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041659

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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