UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056464 |
|---|---|
| Receipt number | R000064526 |
| Scientific Title | The prognosis of asymptomatic lower extremity artery disease patients with iliac artery lesions who incidentally diagnosed on abdominal contrast-enhanced computed tomography |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2025/12/31 14:18:31 |
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Basic information
Public title
The prognosis of asymptomatic lower extremity artery disease patients with iliac artery lesions who incidentally diagnosed on abdominal contrast-enhanced computed tomography
Acronym
The prognosis of asymptomatic lower extremity artery disease patients incidentally diagnosed on abdominal computed tomography
Scientific Title
The prognosis of asymptomatic lower extremity artery disease patients with iliac artery lesions who incidentally diagnosed on abdominal contrast-enhanced computed tomography
Scientific Title:Acronym
The prognosis of asymptomatic lower extremity artery disease patients incidentally diagnosed on abdominal computed tomography
Region
| Japan |
Condition
Condition
lower extremity artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the prognosis of asymptomatic lower extremity artery disease (LEAD) patients incidentally diagnosed on abdominal contrast-enhanced computed tomography (CT), and assess the impact of incidentally diagnosed LEAD to the risk of cardiovascular event even in patients, with no history of ASCVD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major Adverse Cardiovascular Events (MACE): a composite of cardiovascular death, non-fatal MI, non-fatal stroke, and any revascularization
Key secondary outcomes
CardioVascular Event requiring TransFemoral approach (TF-CVE): a composite of cardiogenic shock, acute coronary syndrome, any stroke, and thoracoabdominal aortic aneurysm treated with stent graft
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients underwent abdominal contrast-enhanced CT in Hyogo Prefectural Awaji Medical Center, from January 2014 to March 2021.
Key exclusion criteria
Patients with symptomatic LEAD
Patients with history of ASCVD
Patients who underwent abdominal contrast-enhanced CT for traumatic survey
Patients who underwent revascularization for iliac arterie
Patients whose life expectancy are estimated to less than a year
Patients whose clinical follow-up had ceased after abdominal contrast-enhanced CT date
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo, Japan
TEL
0799-22-1200
k722black@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo, Japan
TEL
0799-22-1200
Homepage URL
k722black@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
Tel
0799-22-1200
Yuri_Maegawa@pref.hyogo.lg.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064526
