UMIN-CTR Clinical Trial

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