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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004241
Receipt No. 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

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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
Email 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
Email masuda@imed2.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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