UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051008 |
|---|---|
| Receipt number | R000058148 |
| Scientific Title | Prediction of Aortic Dissection by Aortic High-risk Lesion Using Non-obstructive Angioscopy |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2023/05/08 20:44:43 |
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Basic information
Public title
Prediction of Aortic Dissection by Aortic High-risk Lesion Using Non-obstructive Angioscopy
Acronym
Prediction of Aortic Dissection by Aortic High-risk Lesion
Scientific Title
Prediction of Aortic Dissection by Aortic High-risk Lesion Using Non-obstructive Angioscopy
Scientific Title:Acronym
Prediction of Aortic Dissection by Aortic High-risk Lesion
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to identify high-risk lesions that may develop into aortic dissection in the future based on the lesion characteristics using an angioscopy that can observe fine damage and atherosclerotic properties of the aorta.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of aortic intimal injury observed by aortic angioscopy and newly observed ULP/PAU on follow-up CT at 2 years
Key secondary outcomes
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
Patients undergoing cardiac catheterization or percutaneous coronary intervention
Patients scheduled to undergo angioscopy
Patients who are clinically at high risk of developing aortic disease and would benefit from a CT scan of the aorta
Patients who give written consent to participate in the study.
Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on a full understanding of the study
Key exclusion criteria
Patients who have had shock or other serious symptoms due to allergy to contrast media
Pregnant, lactating patients or patients who may be pregnant
Patients with cardiogenic shock
Patients with acute aortic dissection or ruptured or imminently ruptured aortic aneurysm
Patients who have refused to participate in this study.
Other patients who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kojima |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-3972-8111
kojima.keisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kojima |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-Kamicho, Itabashi, Tokyo
TEL
09017551938
Homepage URL
kojima.keisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine, Division of Cardiology, Department of Medicine
Institute
Department
Personal name
Keisuke Kojima
Funding Source
Organization
JSPS KAKENHI Grant JP21K16041
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Ohyaguchi-Kamicho, Itabashi, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@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
| 2023 | Year | 05 | Month | 09 | 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
50
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
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prognosis is being tracked.
Management information
Registered date
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058148
