UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029283
Receipt number R000033471
Scientific Title Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention
Date of disclosure of the study information 2017/09/25
Last modified on 2017/09/25 19:06:05

* 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

Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention

Acronym

Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention

Scientific Title

Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention

Scientific Title:Acronym

Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention

Region

Japan


Condition

Condition

patients with stable angina undergoing percutaneous coronary intervention

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate blood biomarkers related with outcomes in patients with stable angina undergoing percutaneous coronary intervention

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, revascularization, and hospitalization for heart failure.

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

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

stable angina pectoris undergoing their first percutaneous coronary intervention

Key exclusion criteria

1.New York Heart Association functional classification of >III
2.malignant disease with an expected prognosis of <1 year
3.chronic inflammatory disease
4.chronic renal failure (serum creatinine concentration of >2.0mg/dl)
5. Patinets who did not provide written informed consent

Target sample size

144


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Hospital

Division name

Cardiovascular Medicine

Zip code


Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7351

Email

miyoshit@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Hospital

Division name

Cardiovascular Medicine

Zip code


Address

2-5-1 Shikada-cho Kita-ku Okayama

TEL

086-235-7351

Homepage URL


Email

miyoshit@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

香川県立中央病院、岡山大学病院


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 25 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

2008 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 08 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

Obsevatonal study


Management information

Registered date

2017 Year 09 Month 25 Day

Last modified on

2017 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033471


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name