UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036564
Receipt number 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 02:13:25

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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 or person

Institute

Osaka Police Hospital

Institute

Department

Personal name



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

Value
https://center6.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