UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016267 |
|---|---|
| Receipt number | R000018878 |
| Scientific Title | The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2017/07/24 10:18:11 |
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Basic information
Public title
The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Acronym
The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Scientific Title
The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Scientific Title:Acronym
The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Region
| Japan |
Condition
Condition
Peripheral arterial disease(PAD), Arteriosclerosis obliterans(ASO)
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the proportion of sarcopenia in PAD patients, and the effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pretreatment of carnitine: cross-sectional areas of skeletal muscle at the thigh and lumbar part, serum carnitine level, absolute claudication distance, symptom, ABI
Post treatment of carnitine: serum carnitine level, absolute claudication distance, symptom, cross-sectional areas of skeletal muscle at the thigh and lumbar part at 6 months after carnitine treatment
Key secondary outcomes
Adverse event, serum carnitine level, absolute claudication distance, symptom at 4 weeks and 3 months after carnitine treatment
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carnitine
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) PAD with intermittent claudication
2) PAD patients desiring for medical treatment
3) The patients obtained informed consent
4) The age over 40 years old
5) Insufficiency of treatment with cilostazole or the difficulty of taking the cilostazole due to side effect
Key exclusion criteria
1) Acute limb ischemia
2) Preferred revascularization for symptoms
3) Comorbidity taking precedence of treatment
4) Bleeding disorders
5) Congestive heart failure
6) Drug allergy of cilostazole or carnitine
7) Pregnant female
8) The patient judged inappropriate by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425466
maehara@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Matsumoto |
Organization
Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5466
Homepage URL
takum@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 26 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | 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
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
