UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004241 |
|---|---|
| Receipt number | R000005097 |
| Scientific Title | Clinical Analysis of Risk Factors Affecting Atherosclerotic Plaque Rupture in Acute Coronary Syndrome |
| Date of disclosure of the study information | 2010/09/21 |
| Last modified on | 2015/10/21 10:12:27 |
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Basic information
Public title
Clinical Analysis of Risk Factors Affecting Atherosclerotic Plaque Rupture in Acute Coronary Syndrome
Acronym
Clinical Analysis of Risk Factors Affecting Atherosclerotic Plaque Rupture in Acute Coronary Syndrome
Scientific Title
Clinical Analysis of Risk Factors Affecting Atherosclerotic Plaque Rupture in Acute Coronary Syndrome
Scientific Title:Acronym
Clinical Analysis of Risk Factors Affecting Atherosclerotic Plaque Rupture in Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of atherogenic factors (remnants, oxidized lipids, oxidized stress and HDL particles) at the acute phase of acute coronary syndrome by the blood collection or histological analysis of thrombus
Basic objectives2
Others
Basic objectives -Others
Changes in each measurement markers
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in each measurement markers
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were admitted to Critical & Cardiovascular Care Unit or Department of Cardiovascular Disease, Osaka Saiseikai Senri Hospital
2) Patients who gave a written informed consent.
Key exclusion criteria
1) Patients who will not agree the written informed consent
2) Patients who are judged by the doctor to be improper to be enrolled in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizuya Yamashita |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3633
shizu@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Masuda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3633
Homepage URL
masuda@imed2.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Critical & Cardiovascular Care Unit or Department of Cardiovascular Disease, Osaka Saiseikai Senri Hospital
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
大阪府立済生会千里病院・千里救命救急センター（大阪府）
大阪大学大学院医学系研究科循環器内科学講座（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The improvement of accumulating remnant lipoproteins were not observed even though patients with ACS were treated with statins.
The accumulation of remnant lipoproteins were associated with the increase in oxidative stress.
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
| 2010 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
At the acute phase of acute coronary syndrome (ACS) and 3, 6, 9, 12, 24, 48, 72 hours after the onset, blood is collected and thrombus is taken by the catheter. We will investigate the influence of atherogenic factors (remnants, oxidized lipids, oxidized stress and HDL particles) by the blood collection or histological analysis of thrombus in ACS patients.
Management information
Registered date
| 2010 | Year | 09 | Month | 21 | Day |
Last modified on
| 2015 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005097
