UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017893 |
|---|---|
| Receipt number | R000020735 |
| Scientific Title | Analysis of the mechanisms regulating the ductus arteriosus closure |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2019/06/18 09:40:48 |
* 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
Analysis of the mechanisms regulating the ductus arteriosus closure
Acronym
Analysis of the mechanisms regulating the ductus arteriosus closure
Scientific Title
Analysis of the mechanisms regulating the ductus arteriosus closure
Scientific Title:Acronym
Analysis of the mechanisms regulating the ductus arteriosus closure
Region
| Japan |
Condition
Condition
Patent ductus arteriosus
Classification by specialty
| Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim was to examine the molecular mechanisms regulating closure of the ductus arteriosus.
Basic objectives2
Others
Basic objectives -Others
1. To identify molecules regulating the ductus arteriosus closure.
2. To confirm the effects of drugs that promote or inhibit the identified molecules on the ductus arteriosus closure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. To identify molecules regulating the ductus arteriosus closure.
2. To confirm the effects of drugs that promote or inhibit the identified molecules on the ductus arteriosus closure.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Tissues of ductus arteriosus are obtained from patients with congenital heart disease at cardiac surgery.
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
| 6 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with congenital heart disease, whose ductus arteriosus is scheduled to be resected at cardiac surgery.
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Utako |
| Middle name | |
| Last name | Utako Yokoyama |
Organization
Yokohama City University Graduate School of Medicine
Division name
Cardiovascular Research Insutitute
Zip code
2360004
Address
3-9 Fukuura Kanazawaku, Yokohama
TEL
045-787-2575
utako@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Utako |
| Middle name | |
| Last name | Yokoyama |
Organization
Yokohama City University Graduate School of Medicine
Division name
Cardiovascular Research Insutitute
Zip code
2360004
Address
3-9 Fukuura Kanazawaku, Yokohama
TEL
045-787-2575
Homepage URL
utako@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura Kanazawaku, Yokohama
Tel
045-787-2800
rinri@fukuhp.yokohama-cu.ac.jp
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | 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
15
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
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
