UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017996 |
|---|---|
| Receipt number | R000020855 |
| Scientific Title | Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment in peripheral artery disease patients |
| Date of disclosure of the study information | 2015/06/21 |
| Last modified on | 2015/10/13 06:21:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Acronym
Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Scientific Title
Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Scientific Title:Acronym
Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Region
| Japan |
Condition
Condition
peripheral artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how Lower limb artery Calcification Assessment with
Dual-Energy Multidetector CT Impacts on endovascular treatment in peripheral artery disease patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
colleration between the ratio of minimum lumen area to reference lumen area in calcified lower limb lesion after endovascular treatment and calcification assessment with Dual-Energy Multidetector CT.
Key secondary outcomes
1 Predictive values of the ratio of minimum lumen area to reference lumen area in calcified lower limb lesion after endovascular treatment in calcification assessment with Dual-Energy Multidetector CT and patients characters.
2 colleration between the ratio of long diameter to short diameter in calcified lower limb lesion after endovascular treatment and calcification assessment with Dual-Energy Multidetector CT.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 patients with endovascular treatment in the lower limb artery with calcified lesions
2 patients with agreement for study
Key exclusion criteria
inappropriate patients determined by study director
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Higashitani |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
Address
3-16-1 asahi-cho Futyu-shi Tokyo
TEL
042-314-3111
mhigashi@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Clinical Trials Support Office |
Organization
Sakakibara Heart Institute
Division name
Clinical Trials Support Office
Zip code
Address
3-16-1 asahi-cho Futyu-shi Tokyo
TEL
042-314-3111
Homepage URL
tikenjim@shi.heart.or.jp
Sponsor or person
Institute
Japan Reserch Promotion Society for Cardiovascular disease
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Heart Institute
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 06 | Month | 21 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1
Management information
Registered date
| 2015 | Year | 06 | Month | 21 | Day |
Last modified on
| 2015 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020855
