UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003510
Receipt number R000004252
Scientific Title Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity
Date of disclosure of the study information 2010/04/20
Last modified on 2010/04/20 12:16:09

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Basic information

Public title

Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity

Acronym

Quantitative coronary optical coherence tomography analysis

Scientific Title

Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity

Scientific Title:Acronym

Quantitative coronary optical coherence tomography analysis

Region

Japan


Condition

Condition

The patients who underwent coronary optical coherence tomography study for the evaluation of restenosis tissue

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the signal attenuation and intensity of coronary optical coherence tomography image, retrospectively; to compare of the quantitative data with clinical demographics, retrospectively; to study the impact of imaging wire location and the reproducibility of the analysis, retrospectively

Basic objectives2

Others

Basic objectives -Others

To predict the lethal stent thrombosis by means of the quantitative optical coherence tomography analysis for restenosis tissue, subjectively and automatically

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

This study retrospectively compares of the clinical and percutaneous coronary intervention related demographics with the quantitative coronary optical coherence tomography data.

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

The patients who underwent the coronary optical coherence tomography study for the evaluation of in-stent restenosis by November 2009.

Key exclusion criteria

Not applicable

Target sample size

17


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takaaki Isshiki

Organization

Teikyo University Hospital

Division name

Division of Cardiology

Zip code


Address

2-11-1, Kaga, Itabashi-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Teikyo University Hospital

Division name

Division of Cardiology

Zip code


Address


TEL


Homepage URL


Email

nsuzu@bronze.ocn.ne.jp


Sponsor or person

Institute

Division of Cardiology, Teikyo University Hospital

Institute

Department

Personal name



Funding Source

Organization

Division of Cardiology, Teikyo University Hospital

Organization

Division

Category of Funding Organization

Other

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

2010 Year 04 Month 20 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

2009 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2009 Year 11 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

Retrospective, observational trial


Management information

Registered date

2010 Year 04 Month 20 Day

Last modified on

2010 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004252


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name