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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name