UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023878 |
|---|---|
| Receipt number | 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 | 2022/03/12 14:56:23 |
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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
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
horitetsu.59123@gmail.com
Public contact
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
horitetsu.59123@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
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
| 2022 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027505
