UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055851 |
|---|---|
| Receipt number | R000063828 |
| Scientific Title | AI-CPX study |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2024/10/16 12:10:11 |
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Basic information
Public title
Machine learning-based individual estimation of heart rate at anaerobic threshold from cardiopulmonary exercise testing - a large-scale study in cardiovascular and healthy population
Acronym
AI-CPX study
Scientific Title
AI-CPX study
Scientific Title:Acronym
AI-CPX study
Region
| Japan |
Condition
Condition
patients with cardiovascular diesease and normal subjects
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a machine learning (ML) approach to predict individualized AT-HR without CPET.
Basic objectives2
Others
Basic objectives -Others
We aimt to reveal important features for predicting AT-HR, which were not used in existing formulas.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart rate at the level of anaerobic threshold, PeakVO2
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
| 8 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiopulmonary function tests at Sakakibara Memorial Hospital
Key exclusion criteria
Cases where it has been done more than once.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
183-0003
Address
3-16-1, Asahi-Chou, Fuchu-City, Tokyo
TEL
0423143111
atsukonakanaka@gmail.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Sakakibara Heart Institute
Zip code
183-0003
Address
3-16-1, Asahi-Chou, Fuchu-City, Tokyo
TEL
0423143111
Homepage URL
atsukonakanaka@gmail.com
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Grant by Sakakibara Heart Fundation, Pfizer Global Health
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
Sakakibara Heart Institute
Address
3-16-1, Asahi-Chou, Fuchu-City, Tokyo
Tel
0423143111
atsukonakanaka@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
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063828
