UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010427 |
|---|---|
| Receipt number | R000012184 |
| Scientific Title | Sexual differences and life change in person with iscemic heart disease from hospital discharge to their home living |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2014/04/07 09:21:56 |
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Basic information
Public title
Sexual differences and life change in person with iscemic heart disease from hospital discharge to their home living
Acronym
Lifestyle rhythms and quality of life among patients with IHD
Scientific Title
Sexual differences and life change in person with iscemic heart disease from hospital discharge to their home living
Scientific Title:Acronym
Lifestyle rhythms and quality of life among patients with IHD
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the sexualdifferences and life change of patients with ischemic heart disease (IHD) who underwent percutaneous coronary intervention (PCI) from hospital discharge to their home living.
Basic objectives2
Others
Basic objectives -Others
Field survey
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of lifes rhythms
Quality of life: Medical Outcomes Study 36-Item Short-Fome
Sexual differences
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) no undergoing comprehensive cardiac rehabilitation (CCR)
(2) the ability to complete a questionnaire
(3) no history of heart failure or life-threatening arrhythmia before PCI
(4) underwent elective PCI of initial therapy or who underwent two or more retreatment by PCI.
Key exclusion criteria
free of chronic psychiatric diseases requiring psychotropic medication, and/or having sleep disorders;
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Yasuhara |
Organization
The University of Tokushima Graduate School
Division name
Department of Nursing, Institute of Health Biosciences,
Zip code
Address
3-18 Kuramoto-cho, Tokushima 770-8509, Japan
TEL
088-633-7629
yasuhara@medsci.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YukoYasuhara |
Organization
The University of Tokushima Graduate School
Division name
Department of Nursing, Institute of Health Biosciences,
Zip code
Address
3-18 Kuramoto-cho, Tokushima 770-8509, Japan
TEL
088-633-7629
Homepage URL
yasuhara@medsci.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 04 | Month | 05 | 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
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
| 2009 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Study
Management information
Registered date
| 2013 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012184
