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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033618
Receipt No. R000038335
Official scientific title of the study 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

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Basic information
Official scientific title of the study The impact of Recanalization of Chronic Total Occuled Coronary Artery on Electrophysiological Substate of Left Ventricle
Title of the study (Brief title) 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 Kennosuke Yamashita
Organization Showa University Northern Yokohama Hospital
Division name Cardiology
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 Kennosuke Yamashita
Organization Showa University Northern Yokohama Hospital
Division name Cardiology
Address 35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama city, Kanagawa, Japan
TEL 045-949-7000
Homepage URL
Email kennosuke.atmm3@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.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


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