UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015072
Receipt number R000017535
Scientific Title Association of Localized Hypersensitivity and In-Stent Neoatherosclerosis with the Very Late Drug-eluting Stent Thrombosis
Date of disclosure of the study information 2014/09/05
Last modified on 2014/09/05 22:18:00

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Basic information

Public title

Association of Localized Hypersensitivity and In-Stent Neoatherosclerosis with the Very Late Drug-eluting Stent Thrombosis

Acronym

hypersensitivity and neoatherosclerosis in DES ST

Scientific Title

Association of Localized Hypersensitivity and In-Stent Neoatherosclerosis with the Very Late Drug-eluting Stent Thrombosis

Scientific Title:Acronym

hypersensitivity and neoatherosclerosis in DES ST

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The present study sought to explore the prevalence of inflammatory cell infiltrates and evidence for fragments of atherosclerotic plaques in the aspirated thrombi in patients with very late drug-eluting stent thrombosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Histopathlogic evaluation of the prevalence of inflammatory cell infiltrates and evidence for fragment\s of atherosclerotic plaques

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

Patients with stent thrombosis who underwent thrombus aspiration

Key exclusion criteria

None

Target sample size

105


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyohei Yamaji

Organization

Kokura Memorial Hospital

Division name

Division of Cardiology

Zip code


Address

Kokurakita Asano 3-2-1, Kitakyushu

TEL

+81-93-511-2000

Email

kyohei@yamaji.info


Public contact

Name of contact person

1st name
Middle name
Last name Kyohei Yamaji

Organization

Kokura Memorial Hospital

Division name

Division of Cardiology

Zip code


Address

Kokurakita Asano 3-2-1, Kitakyushu

TEL

+81-93-511-2000

Homepage URL


Email

kyohei@yamaji.info


Sponsor or person

Institute

Kokura Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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 09 Month 05 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 01 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We identified 105 patients who underwent percutaneous coronary intervention (PCI) for angiographically confirmed definite stent thrombosis (ST) of DES. Of those, 48 patients with stent thrombosis (ST) of DES underwent thrombus aspiration with retrieved material sufficient for the histopathologic analysis.


Management information

Registered date

2014 Year 09 Month 05 Day

Last modified on

2014 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017535


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name