UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020276 |
|---|---|
| Receipt number | R000023407 |
| Scientific Title | Impressive Predictive Value of Ankle Brachial Index for Very Long Term Outcome in Patients with Cardiovascular Disease |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/06/22 10:51:58 |
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Basic information
Public title
Impressive Predictive Value of Ankle Brachial Index for Very Long Term Outcome in Patients with Cardiovascular Disease
Acronym
Impressive Predictive Value of Ankle Brachial Index for Very Long Term Outcome in Patients with Cardiovascular Disease(IMPACT-ABI study)
Scientific Title
Impressive Predictive Value of Ankle Brachial Index for Very Long Term Outcome in Patients with Cardiovascular Disease
Scientific Title:Acronym
Impressive Predictive Value of Ankle Brachial Index for Very Long Term Outcome in Patients with Cardiovascular Disease(IMPACT-ABI study)
Region
| Japan |
Condition
Condition
patients who were hospitalized for cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the relationship between the long term future cardiovascular events and ABIin patinets with cardiovasculr disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was MACE (cardiovascular death, myocardial infarction and stroke).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who were hospitalized for cardiovascular disease and measured by ABI from January 2005 to December 2012.
Key exclusion criteria
Patinets who dose not give informed consent
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Miura |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-3 Asahi, Matsumoto, Japan 390-8621
TEL
026-335-4600
miuramen10miuramen@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miura |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-3 Asahi, Matsumoto, Japan 390-8621
TEL
026-335-4600
Homepage URL
miuramen10miuramen@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Shinshu University School of Medicine
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
| 2016 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2015 | Year | 12 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023407
