UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033618
Receipt number R000038335
Scientific Title The impact of Recanalization of Chronic Total Occuled Coronary Artery on Electrophysiological Substate of Left Ventricle
Date of disclosure of the study information 2018/08/03
Last modified on 2018/08/03 06:11:44

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Basic information

Public title

The impact of Recanalization of Chronic Total Occuled Coronary Artery on Electrophysiological Substate of Left Ventricle

Acronym

The relaionship of chronic total occluded coronary artery and electrophysiological remodeling

Scientific Title

The impact of Recanalization of Chronic Total Occuled Coronary Artery on Electrophysiological Substate of Left Ventricle

Scientific Title:Acronym

The relaionship of chronic total occluded coronary artery and electrophysiological remodeling

Region

Japan


Condition

Condition

ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our purpose of this study is to assess the effect of CTO recanalization on left ventricular voltage change using paired electrophysiological findings

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of low voltage zone in left ventricle 8 months after percutaneous coronary intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Percutaneous coronary intervention

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

Consecutive patiens with chronic total occluded artery who experience percutaneous intervention

Key exclusion criteria

1) ACS
2) Pregnant
3) Hemodialysis
4) Uncontrollable or poor controled hypertension
5) Uncontrollable or poor controled diabetes mellitus
6) Liver dysfunction (ALT > 100 IU/L, AST > 100 IU/L, Total Bilirubin > 2.5 mg/dL)
7) Kidney dysfunction (Serum Creatinine > 20 mg/dL, Ccr < 30 mL/min/1.73 m2)
8) Creatinine Kinase > 500 IU/L
9) Patients who are judged to be inappropriate by investigator

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kennosuke Yamashita

Organization

Showa University Northern Yokohama Hospital

Division name

Cardiology

Zip code


Address

35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama city, Kanagawa, Japan

TEL

045-949-7000

Email

kennosuke.atmm3@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kennosuke Yamashita

Organization

Showa University Northern Yokohama Hospital

Division name

Cardiology

Zip code


Address

35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama city, Kanagawa, Japan

TEL

045-949-7000

Homepage URL


Email

kennosuke.atmm3@gmail.com


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

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

2018 Year 08 Month 03 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2015 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2015 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



Management information

Registered date

2018 Year 08 Month 03 Day

Last modified on

2018 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038335


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name