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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
