UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015717
Receipt number R000018273
Scientific Title Role of matrix metalloproteinase for organization of clot in CTEPH
Date of disclosure of the study information 2014/11/18
Last modified on 2016/11/28 15:34:55

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Basic information

Public title

Role of matrix metalloproteinase for organization of clot in CTEPH

Acronym

Role of matrix metalloproteinase for organization of clot in CTEPH

Scientific Title

Role of matrix metalloproteinase for organization of clot in CTEPH

Scientific Title:Acronym

Role of matrix metalloproteinase for organization of clot in CTEPH

Region

Japan


Condition

Condition

Chronic thromboembolic pulmonary hypertension

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate a role of Matrix metalloproteinase in organization of clots in CTEPH.

Basic objectives2

Others

Basic objectives -Others

To pathologically evaluate surgical specimens.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To reveal association between matrix metalloproteinase and degradation of extracellular matrix and development of neovasucular formation by means of evaluation of surgical specimens

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients undergoing pulmonary endarterectomy for CTEPH

Key exclusion criteria

no exclusion criteria

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiichi Ishida

Organization

Chiba University, School of Medicine

Division name

Department of General Medical Science

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL

043-222-7171

Email

keiichi-ishida@pro.odn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiichi Ishida

Organization

Chiba University, School of Medicine

Division name

Department of General Medical Science

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

keiichi-ishida@pro.odn.ne.jp


Sponsor or person

Institute

Chiba University, School of Medicine, Department of Cardiovascular Surgery

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 18 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

2013 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 11 Day

Last follow-up date


Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 12 Month 30 Day

Date analysis concluded

2016 Year 01 Month 30 Day


Other

Other related information

This study deals with surgical specimens


Management information

Registered date

2014 Year 11 Month 18 Day

Last modified on

2016 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018273