UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014713
Receipt No. 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

* 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 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
Last 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
Email tomoyamukai@gmail.com

Public contact
1st 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
Email tomoyamukai@gmail.com

Sponsor
Institute Kajikawa Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.