UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038912 |
|---|---|
| Receipt number | R000044366 |
| Scientific Title | Prognostic value of sarcopenia on mortality in patients with cardiovascular disease |
| Date of disclosure of the study information | 2019/12/17 |
| Last modified on | 2021/04/27 10:28:36 |
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Basic information
Public title
Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Acronym
Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Scientific Title
Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Scientific Title:Acronym
Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Region
| Japan |
Condition
Condition
Patients with cardiovascular disease including congestive heart failure and acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prognostic value of skeletal muscle dysfunction in patients with cardiovascular disease
Basic objectives2
Others
Basic objectives -Others
Evaluation of skeletal muscle dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
In-hospital mortality
Cardiovascular death
Heart Failure rehospitalization
Acute kidney injury/worsening renal function
Urine output during hospitalization
Skeletal muscle mass
Brain-derived neurotrophic factor (BDNF)
Gait speed
Grip strength
Maximal oxygen consumption
Bioelectrical Impedance analysis (BIA)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalizaed with acute heart failure or acute myocardial infarction
Key exclusion criteria
1)Patients with out-of-hospital cardiac arrest
2)Patients with malignant disease with life expectancy within 1 year
3)Patinets with no obtained informed concent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hirakata Kohsai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology, Kindai University
Address
377-2, Ohnohigashi, Osaasayama
Tel
+8172366-0221
kmatsumura1980@yahoo.co.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
枚方公済病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Evaluation of treatment detail during hospitalization and subsequent long-term outcome
Management information
Registered date
| 2019 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044366
