UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025736
Receipt No. R000029611
Scientific Title The association between insomnia and endothelial function in ischemic heart disease patients
Date of disclosure of the study information 2017/01/19
Last modified on 2017/07/21

* 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 association between insomnia and endothelial function in ischemic heart disease patients
Acronym Research in the secondary prevention of ischemic heart disease
Scientific Title The association between insomnia and endothelial function in ischemic heart disease patients
Scientific Title:Acronym Research in the secondary prevention of ischemic heart disease
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between endothelial function and insomnia in ischemic heart disease patients.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endothelial function evaluated by endopat2000

Key secondary outcomes Pittsburgh Sleep Quality Index
Sleep quality evaluated by watchpat

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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Ischemic heart disease patients under the control of coronary risk factors in our hospital
Patients who gave written informed consent
Key exclusion criteria Pregnancy
Patients who had an acute coronary syndrome or a stroke within 3 months
To be judged ineligible by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Nakao
Organization The University of Tokyo Hospital
Division name Department of Clinical Laboratory
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email ihd.prevention@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Nakao
Organization The University of Tokyo Hospital
Division name Department of Clinical Laboratory
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email ihd.prevention@gmail.com

Sponsor
Institute Department of Clinical Laboratory, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Itamar Medical Japan Co. Ltd
Name of secondary funder(s) Itamar Medical Japan Co. Ltd

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
2017 Year 01 Month 19 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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study to investigate the association between endothelial function and insomnia in ischemic heart disease patients.

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2017 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.