UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045056 |
|---|---|
| Receipt number | R000051425 |
| Scientific Title | Factors predicting weight loss associated with poor prognosis after acute myocardial infarction |
| Date of disclosure of the study information | 2021/08/03 |
| Last modified on | 2024/08/10 16:34:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Factors predicting weight loss associated with poor prognosis after acute myocardial infarction
Acronym
Factors predicting weight loss associated with poor prognosis after acute myocardial infarction
Scientific Title
Factors predicting weight loss associated with poor prognosis after acute myocardial infarction
Scientific Title:Acronym
Factors predicting weight loss associated with poor prognosis after acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1,To determine the rate at who weight loss with muscle mass loss occurs after AMI using a body composition analyzer.
2,To determine the factors that predict weight-loss with muscle mass loss from body composition, exercise tolerance, muscle strength, and various tests in the early stage after AMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight-loss with loss of muscle mass at 9 months and 3-4 years after discharge
Key secondary outcomes
Weight(at admission, at discharge, 9 months after discharge and 3-4 years after discharge)
Body mass index(at discharge, 9 months after discharge and 3-4 years after discharge)
Skeletal muscle mass(at discharge ,9 months after discharge and 3-4 years after discharge)
Skeletal muscle index(at discharge, 9 months after discharge and 3-4 years after discharge)
Body fat percentage(at discharge, 9 months after discharge and 3-4 years after discharge)
Phase angle(at discharge, 9 months after discharge and 3-4 years after discharge)
Grip strength(at discharge, 9 months after discharge and 3-4 years after discharge)
Isometric knee extension strength(at discharge, 9 months after discharge and 3-4 years after discharge)
Mini nutritional assessment(at discharge, 9 months after discharge and 3-4 years after discharge)
International physical activity questionnaire long version:IPAQ LV(at discharge, 9 months after discharge and 3-4 years after discharge)
Arm circumference(at discharge, 9 months after discharge and 3-4 years after discharge)
Calf circumference(at discharge, 9 months after discharge and 3-4 years after discharge)
Anaerobic threshold, VE/VCO2 slope, OUES, PETO2, delta PETO2, PETCO2, delta PETCO2, OUES, WR at AT, delta VO2/delta WR and delta HR by cardiopulmonary exercise test(at discharge)
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 admitted for acute myocardial infarction and underwent percutaneous coronary intervention
Key exclusion criteria
1,Persons who rehabilitation was not performed
2,Persons who implanted pacemakers or defibrillators
3,Persons who contraindications to cardiopulmonary exercise testing
4,Persons who underwent a cardiopulmonary exercise testing but could not determine the anaerobic metabolic threshold
5,Persons who are judged by a physician should not performed a cardiopulmonary exercise testing
6,Persons who did not obtain consent to participate in the research
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Utsumi |
Organization
Tokushima Red Cross Hospital
Division name
Department of Rehabilitation
Zip code
773-8502
Address
Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL
0885-32-2555
utsumi0827@gmail.com
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Utsumi |
Organization
Tokushima Red Cross Hospital
Division name
Department of Rehabilitation
Zip code
773-8502
Address
Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL
0885-32-2555
Homepage URL
utsumi0827@gmail.com
Sponsor or person
Institute
Tokushima Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Public Benefit Trust, Tanita Health and Weight Fund
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
Department of General Affairs,Tokushima Red Cross Hospital
Address
Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
Tel
0885-32-2555
soumu@tokushima-med.jrc.or.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
徳島赤十字病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective cohort study.
Management information
Registered date
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051425
