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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023878
Receipt No. R000027505
Scientific Title The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/31

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Basic information
Public title The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis
Acronym The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease
Scientific Title The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis
Scientific Title:Acronym The Impact of Exercise Treatment on Blood Flow of Lower Limb 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 examine the mechanism of an blood flow increase after exercise treatment or injection of papaverine on lower limbs using an combined pressure and flow wire (Combo wire, Volcano corporation)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of pressure and blood flow after exercise treatment and injection of papaverine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Insertion of Combo wire
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 Patients who have symptomatic peripheral artery disease with one-sided or bilateral occluded iliac artery lesions
Key exclusion criteria 1. Patients with allergic to contrast media
2. Patients who is decided into inadequate for this study by attending physician
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masaharu Ishihara
Organization Hyogo College of Medicine
Division name Division of cardiovascular disease and coronary heart disease
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6111
Email horitetsu.59123@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Tetsuo Horimatsu
Organization Hyogo College of Medicine
Division name Division of cardiovascular disease and coronary heart disease
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6111
Homepage URL
Email horitetsu.59123@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 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
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027505

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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