UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044006 |
|---|---|
| Receipt number | R000050237 |
| Scientific Title | Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event. |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2024/04/25 16:15:34 |
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Basic information
Public title
Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event.
Acronym
Establishment of predictive indicator for cardiovascular event using simple sarcopenia screening method.
Scientific Title
Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event.
Scientific Title:Acronym
Establishment of predictive indicator for cardiovascular event using simple sarcopenia screening method.
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prediction ability of simple screening method for sarcopenia for cardiovascular events.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the predictive ability for adverse events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of cardiovascular events
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 calculated simple screening score for sarcopenia
Key exclusion criteria
Nothing
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken
TEL
+81963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Hanatani |
Organization
Kumamoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken
TEL
+81963735175
Homepage URL
s-hanata@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken
Tel
+81963735175
s-hanata@kumamoto-u.ac.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
| 2021 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41366-021-00895-2
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41366-021-00895-2
Number of participants that the trial has enrolled
1218
Results
Of the 262 patients, 108 had a high sarcopenia score based on previously established criteria. Kaplan Meier curves revealed a significantly lower event-free survival rate in those with a high compared with a low sarcopenia score (log-rank test p=0.001). Multivariate Cox proportional hazard analysis identified a high sarcopenia score (hazard ratio: 2.46; 95% confidence interval: 1.31-4.64, p=0.005) as an independent predictor of the primary endpoints.
Results date posted
| 2024 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We calculated the sarcopenia score in 262 patients with abdominal obesity, defined as a waist circumference over 90 cm in women or over 85 cm in men. The composite endpoint of this study was cardiovascular mortality, nonfatal myocardial infarction, stroke, unstable angina, and heart failure hospitalization.
Participant flow
We calculated the sarcopenia score in 262 patients with abdominal obesity.
Adverse events
N.A
Outcome measures
The composite endpoint of this study was cardiovascular mortality, nonfatal myocardial infarction, stroke, unstable angina, and heart failure hospitalization.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow-up of cardiovascular events
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050237
