UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033050 |
|---|---|
| Receipt number | R000037684 |
| Scientific Title | The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2023/06/29 07:58:11 |
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Basic information
Public title
The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease
Acronym
PAD-CPX study
Scientific Title
The effect of endovascular therap y on the exercise tolerance of peri pheral arterial disease
Scientific Title:Acronym
PAD-CPX study
Region
| Japan |
Condition
Condition
Peripheral arterial disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The exercise capacity of peripher al arterial disease is limited for th e flow limit to the lower extremiti es. The aim of ths study is to inve stigate the effect of the endovascu lar therapy on exercise tolerance of peripheral arterial disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The exercise tolerance (AT, peak VO2, 6MWD)
We evaluate these parameters bef ore EVT, immedeately after EVT a nd 3 months after EVT.
Key secondary outcomes
The subjective symptoms (Rutherf ord class)
The periperal circulation index (A BI, SPP)
Other index of the cardiopulmona ry exercise test.
Cardiac function.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Symptomatic PAD patient (>=Rutherford : Category 2) refractory to t he standard non-invasive treatme nt (exercise and/or medical treat ment)
Key exclusion criteria
Clinical Lim ischemia
people who do not bicycle Severe coronary artery disease Severe LV dysfunction
Severe arrhythmia
Pregnancy
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Shigeyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Mito Kyodo General Hospital
Division name
Cardiology Department
Zip code
310-0015
Address
3-2-7 Miya-Machi Mito Japan
TEL
029-231-2371
watanabe.s.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Toyama |
Organization
Mito Kyodo General Hospital
Division name
Cardiology Department
Zip code
301--0015
Address
3-2-7 Miya-Machi Mito Japan
TEL
029-231-2371
Homepage URL
mt@mail1.accsnet.ne.jp
Sponsor or person
Institute
Mito Kyodo General Hospital Cardiology Department
Institute
Department
Personal name
Funding Source
Organization
Mito Kyodo General Hospital Cardiology Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mito Kyodo General Hospital
Address
3-2-7 Miya-Machi Mito Japan
Tel
029-231-2371
mt@mail1.accsnet.ne.jp
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
筑波大学附属病院水戸地域医療教育センター・水戸協同病院(茨城県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 20 | 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
| 2018 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Terminated
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037684
