UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019148 |
|---|---|
| Receipt number | R000022140 |
| Scientific Title | Risk factors of cerebral infarction in the elderly: Effects of aging and types of ischemic stroke |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/09/29 16:02:22 |
* 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
Risk factors of cerebral infarction in the elderly: Effects of aging and types of ischemic stroke
Acronym
Risk factors of cerebral infarction in the elderly: Effects of aging and types of ischemic stroke
Scientific Title
Risk factors of cerebral infarction in the elderly: Effects of aging and types of ischemic stroke
Scientific Title:Acronym
Risk factors of cerebral infarction in the elderly: Effects of aging and types of ischemic stroke
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The risk factors between the types of ischemic stroke (atherosclerotic,cardiogenic and lacunar infarction) have never compared each other. To determine whether the risk factors of the patients with cerebral infarction were different or not between the elderly patients with an age of>75 and <75 and types of ischemic stroke,we compared clinical parameters between them in a cross-sectional study.
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigated several clinical parameters (height, body weight, body mass index (BMI), systolic blood pressure and diastolic blood pressure), some hemodynamic and cardiac parameters. The following variables were measured; serum lipid levels (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol and triglyceride), glycosylated hemoglobin (HbA1c) value, hemoglobin (Hb) value, serum total protein (TP) levels, albumin (Alb) level, renal function parameters (blood urea nitrogen, serum creatinine and estimated glemerular filtration rate (eGFR)), liver function parameters (serum aspartate aminotransferase and alanine aminotransferase). We also investigated cardiac parameters, including the presence/absence of left ventricular hypertrophy (LVH) as evaluated by 12-lead ECG, the cardiothoracic ratio (CTR) measured on a chest X-ray and left atrial dimension (LAD), left ventricular end-diastolic dimension (LVDd), left ventricular end-systolic diameter (LVESD), interventricular septum thickness (IVST), left ventricular posterior wall thickness (LVPWth), aortic dimension and ejection fraction (EF) measured on a cardiac echo. Similarly, we investigated the carotid artery plaque score by carotid echo to evaluate the risk factor of atherosclerosis.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
300 acute stroke; 150 with an age of>75 and 150 of <75 (both 150 included atherosclerotic: ATI,cardiogenic: CEI and lacunar stroke: LS of 50 each)
Key exclusion criteria
non
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidezo Mori |
Organization
School of medicine, Tokai University
Division name
Department of Physiology
Zip code
Address
143 Shimokasuya Isehara Kanagawa Japan
TEL
0463-93-1121
at067659@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayato Fukui |
Organization
School of medicine, Tokai University
Division name
Department of Physiology
Zip code
Address
143 Shimokasuya Isehara Kanagawa Japan
TEL
0463-93-1121
Homepage URL
sfukui@tsc.u-tokai.ac.jp
Sponsor or person
Institute
School of medicine, Tokai University
Institute
Department
Personal name
Funding Source
Organization
School of medicine, Tokai University
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
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
School of medicine, Tokai University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigated several clinical parameters (height, body weight, body mass index (BMI), systolic blood pressure and diastolic blood pressure), some hemodynamic and cardiac parameters. The following variables were measured; serum lipid levels (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol and triglyceride), glycosylated hemoglobin (HbA1c) value, hemoglobin (Hb) value, serum total protein (TP) levels, albumin (Alb) level, renal function parameters (blood urea nitrogen, serum creatinine and estimated glemerular filtration rate (eGFR)), liver function parameters (serum aspartate aminotransferase and alanine aminotransferase). We also investigated cardiac parameters, including the presence/absence of left ventricular hypertrophy (LVH) as evaluated by 12-lead ECG, the cardiothoracic ratio (CTR) measured on a chest X-ray and left atrial dimension (LAD), left ventricular end-diastolic dimension (LVDd), left ventricular end-systolic diameter (LVESD), interventricular septum thickness (IVST), left ventricular posterior wall thickness (LVPWth), aortic dimension and ejection fraction (EF) measured on a cardiac echo. Similarly, we investigated the carotid artery plaque score by carotid echo to evaluate the risk factor of atherosclerosis.
To identify the risk factors, we carried out one-way analysis of variance (one-way ANOVA) using factors among three subtypes and student t-test with an age of>75 and <75.
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022140
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
