UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029746 |
|---|---|
| Receipt number | R000033983 |
| Scientific Title | Evaluation of Ruptured Aortic Plaque in Patients with or Suspected Peripheral Artery Disease by Non-obstructive ANgioscopy |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2017/10/28 23:40:10 |
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Basic information
Public title
Evaluation of Ruptured Aortic Plaque in Patients with or Suspected Peripheral Artery Disease by Non-obstructive ANgioscopy
Acronym
Evaluation of Ruptured Aortic Plaque in Patients with Peripheral Artery Disease
Scientific Title
Evaluation of Ruptured Aortic Plaque in Patients with or Suspected Peripheral Artery Disease by Non-obstructive ANgioscopy
Scientific Title:Acronym
Evaluation of Ruptured Aortic Plaque in Patients with Peripheral Artery Disease
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the components of spontaneous ruptured plaque in patients with peripheral artery disease by imaging and/or pathology
Basic objectives2
Others
Basic objectives -Others
cross-sectional observational
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation of ruptured aortic plaque for peripheral artery disease
Key secondary outcomes
Obtaining the atherosclerosis imaging by non-obstructive angioscopy and pathology
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
patients who underwent Percutaneous Transluminal Angioplasty or Aspiration therapy
Key exclusion criteria
use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability, known aortic dissection, aortic aneurysm larger than the size indicated for surgery (thoracic diameter >=6 mm or abdominal diameter>=5 mm), allergy to contrast media, and pregnancy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kauzhisa Kodama, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, Osaka
TEL
06-6462-0261
ascopy_kdm@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sei Komatsu, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, 554-0012, Osaka
TEL
06-6462-0261
Homepage URL
plaquemap@yahoo.co.jp
Sponsor or person
Institute
Cardiovascular Center, Osaka Gyoumeikan Hospital
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Center, Osaka Gyoumeikan 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
Address
Tel
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
大阪暁明館病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the percutaneous transluminal angioplasty or aspiration for peripheral artery disease, sampling for atheroma with protection device will be performed. The findings will be compared patientss' characteristics and aortic imaging such as angioscopy, CT, MRI, and echo.
Management information
Registered date
| 2017 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033983
