UMIN-CTR Clinical Trial

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
Email	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
Email	shiori.maruichi@gmail.com

Sponsor
Institute	Osaka Red Cross Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054651