UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047939 |
|---|---|
| Receipt number | R000054651 |
| Scientific Title | A Retrospective Study of AI to Predict Prognosis in Patients with Critical Limb Ischemia |
| Date of disclosure of the study information | 2022/06/25 |
| Last modified on | 2022/06/03 13:39:51 |
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Basic information
Public title
A Retrospective Study of AI to Predict Prognosis in Patients with Critical Limb Ischemia
Acronym
A Retrospective Study of AI to Predict Prognosis in Patients with Critical Limb Ischemia
Scientific Title
A Retrospective Study of AI to Predict Prognosis in Patients with Critical Limb Ischemia
Scientific Title:Acronym
A Retrospective Study of AI to Predict Prognosis in Patients with Critical Limb Ischemia
Region
| Japan |
Condition
Condition
Critical Limb Ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prognosis for patients with critical leg ischemia is poor, requiring early testing and treatment to save lives and limbs. Catheter-based examination and treatment (peripheral angioplasty) is performed, but many patients are at high risk, and it is important to assess whether they would benefit from revascularization.
Basic objectives2
Others
Basic objectives -Others
In this study, we will make AI learn the images at the time of catheterization and the subsequent course of the procedure to analyze the prognosis by images.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all cause death and major 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
Patients undergoing peripheral angioplasty at Osaka Red Cross Hospital from January 1, 2016 to June 3, 2022
Key exclusion criteria
Patients who cannot give consent for this study, patients with serious illnesses that are predicted to significantly affect their prognosis (e.g., malignancy requiring current treatment, severe infection, severe immunological or metabolic disease, etc.)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Inada |
Organization
Osaka Red Cross Hospital
Division name
Cardiology
Zip code
543-8555
Address
5-30 Fudekazaki-cho, Tennoji-ku, Osaka City
TEL
06-6774-5111
itsuka@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Kawakami |
Organization
Osaka Red Cross Hospital
Division name
Cardiology
Zip code
543-8555
Address
5-30 Fudekazaki-cho, Tennoji-ku, Osaka City
TEL
06-6774-5111
Homepage URL
shiori.maruichi@gmail.com
Sponsor or person
Institute
Osaka Red Cross Hospital
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
Osaka Red Cross Hospital
Address
5-30 Fudekazaki-cho, Tennoji-ku, Osaka City
Tel
06-6774-5111
shiori.maruichi@gmail.com
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
| 2022 | Year | 06 | Month | 25 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054651
