UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014713 |
|---|---|
| Receipt number | R000017102 |
| Scientific Title | Correlation between the accumulation of chylomicron remnants and the morbidity of cerebrovascular disease |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2018/08/03 05:41:10 |
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Basic information
Public title
Correlation between the accumulation of chylomicron remnants and the morbidity of cerebrovascular disease
Acronym
Correlation between the accumulation of chylomicron remnants and the morbidity of cerebrovascular disease
Scientific Title
Correlation between the accumulation of chylomicron remnants and the morbidity of cerebrovascular disease
Scientific Title:Acronym
Correlation between the accumulation of chylomicron remnants and the morbidity of cerebrovascular disease
Region
| Japan |
Condition
Condition
Cerebral infarction and cerebral bleeding
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the correlation between the accumulation of chylomicron remnants and cerebrovascular disease. Concentrations of apolipoprotein (apo) B-48 and remnant lipoprotein cholesterol (RemL-C) levels are measured in patients who are admitted the hospital and compared with the pathogenesis of cerebrovascular disease and concentrations of other biomarkers. We will evaluate the pathophysiology of dyslipidemia including the accumulation of remnants in patients with cerebrovascular diseases.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlations between the pathophysiology of cerebrovascular diseases and concentrations of following biomarkers ; apolipoprotein B-48, remnant lipoprotein cholesterol(RemL-C), adiponectin and free fatty acids
Key secondary outcomes
Correlations between concentrations of former biomarkers and following classical biomarkers ; blood cell count, total cholesterol, TG, HDL-C, LDL-C, fasting blood glucose, HbA1c, GOT, GPT, Cr, BUN, CCr, APTT, PT, fibrinogen, FDP, D-dimer, Urinary Albumin
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A patient admitted to Kajikawa Hospital with cerebral bleeding or cerebral infarction diagnosed by the doctor
2. Patient within seven days from the onset of cerebrovascular event at the time of informed consent
3. Men and women at 20 years of age or more
Key exclusion criteria
1. A subject under 20 years of age
2. A patient with hemodialysis
3. A patient who do not obtain approval from the legal representative or the person himself
4. A patient whom the doctor judged inappropriate for the enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Imamura |
Organization
Kajikawa Hospital
Division name
Department of Neurology
Zip code
Address
8-20, Shouwa-cho, Naka-ku, Hiroshima city, Hiroshima, 730-0046, Japan
TEL
082-249-6411
tomoyamukai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Mukai |
Organization
Hiroshima University Hospital
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima-city, Hiroshima 734-8551, Japan
TEL
082-257-5201
Homepage URL
tomoyamukai@gmail.com
Sponsor or person
Institute
Kajikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Neuroscience and Therapeutics, Hirosima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Peripheral blood was collected from patients with cerebrovascular diseases at admission to Kajikawa hospital, the day after admission and at the time of discharge. New marker for the accumulation of chylomicron remnants including apoB-48 concentrations will be measured and the correlations of new markers with the pathophysiology of cerebrovascular diseases and other classical biomarkers measured in Kajikawa hospital.
Management information
Registered date
| 2014 | Year | 07 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017102
