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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011100
Receipt No. R000013000
Scientific Title Estimation of skeletal calf muscle perfusion using MRI
Date of disclosure of the study information 2013/07/08
Last modified on 2013/07/02

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Basic information
Public title Estimation of skeletal calf muscle perfusion using MRI
Acronym muscle perfusion by MRI
Scientific Title Estimation of skeletal calf muscle perfusion using MRI
Scientific Title:Acronym muscle perfusion by MRI
Region
Japan

Condition
Condition diabetes mellitus
arteriosclerosis obliterans
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preliminary trial for quantitative estimation of the skeletal muscle
Basic objectives2 Others
Basic objectives -Others Quantitative estimation in vivo
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of perfusion and diffusion components by DWI
The correlation between BOLD and actual blood flow
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 pressing of femoral artery
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
30 years-old >
Gender Male
Key inclusion criteria Normal
DM
ASO
Key exclusion criteria not normal, DM, nor ASO
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Okamoto
Organization University of Tsukuba Hospital
Division name Radiology and IVR
Zip code
Address 2-1-1Amakubo Tsukuba Ibaraki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tsukuba Hospital
Division name Radiology and IVR
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
2013 Year 07 Month 08 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 Preinitiation
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 08 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
2013 Year 07 Month 02 Day
Last modified on
2013 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013000


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