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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029746
Receipt No. 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

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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
Email 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
Email plaquemap@yahoo.co.jp

Sponsor
Institute Cardiovascular Center, Osaka Gyoumeikan Hospital
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033983

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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