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

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 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


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

Value
https://center6.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