UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017331
Receipt No. R000020108
Scientific Title Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry)
Date of disclosure of the study information 2015/04/29
Last modified on 2020/05/06

* 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 Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry)
Acronym Showa PAD registry
Scientific Title Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry)
Scientific Title:Acronym Showa PAD registry
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 analyse the current status and prognosis in peripheral artery disease
Basic objectives2 Others
Basic objectives -Others A multicenter epidemiology observational study to determine the frequency of the event about the characteristics of the patients group with PAD and the health and distribution and a factor to affect
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes All-cause death, cardiac death, cardiovascular death, non-cardiac death, non-cardiovascular death, admission (heart failure, myocardial infarction, cerebral infarction, critical limb ischemia), limb amputation
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ankle brachial index (ABI) <1.0
Toe brachial index (TBI) <0.6
Skin purfusion pressure (SPP) <60mmHg
Key exclusion criteria 1) Patients once registered in this study
2) Patients unable to follow up
3) Patietns with poor prognosis with cancer
4) Patietns doctors decide not eligible
5) ABI, TBI, SPP were not met the criteria after recanalization therapy
Target sample size 700

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Suzuki
Organization Showa Univeristy Fujigoka Hospital
Division name Department of Cardiology
Zip code 227-8501
Address 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL 0459711151
Email hrsuzuki@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Suzuki
Organization Showa Univeristy Fujigoka Hospital
Division name Department of Cardiology
Zip code 227-8501
Address 1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Jaoan
TEL 81-45-971-1151
Homepage URL
Email hrsuzuki@med.showa-u.ac.jp

Sponsor
Institute Showa Univeristy Fujigoka Hospital
Institute
Department

Funding Source
Organization Showa Univeristy Fujigoka Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Fujigaoka Hospital
Address 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
Tel 0459711151
Email hrsuzuki@med.showa-u.ac.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 昭和大学藤が丘病院(神奈川県)、昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 29 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
2014 Year 10 Month 01 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) All-cause death (2) Cardiac death (3) Cardiovascular death (4) Non-cardiac death (5) Non-cardiovascular death (6) Admission in heart failure (7) Admission in myocardial infarction (8) Admission in cerebral infarcition (9) Admission in critical limb ischemia (10) Limb amputation

Management information
Registered date
2015 Year 04 Month 29 Day
Last modified on
2020 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.