UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035014 |
|---|---|
| Receipt number | 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 | 2021/04/19 16:11:03 |
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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 | Kazuhisa |
| Middle name | |
| Last name | Kodama |
Organization
Osaka Police hospital
Division name
cardiology
Zip code
543-0035
Address
10-31 Kitayama-cho, Tenoji-ku, Osaka city
TEL
06-6771-6051
ascopy_kdm@yahoo.co.jp
Public contact
Name of contact person
| 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, itabashiku, Tokyo
TEL
03-3972-8111
Homepage URL
atsushi-hirayama@oph.gr.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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 | 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
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039916
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
