UMIN-CTR Clinical Trial

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 Tomoko Middle name Last name Nakao
Organization	The University of Tokyo Hospital
Division name	Department of Clinical Laboratory
Zip code	1138655
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 Tomoko Middle name Last name Nakao
Organization	The University of Tokyo Hospital
Division name	Department of Clinical Laboratory
Zip code	113-8655
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	Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 19 Day

Related information
URL releasing protocol	https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-26860545/
Publication of results	Partially published

Result
URL related to results and publications	https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-26860545/
Number of participants that the trial has enrolled	101
Results	No significant correlation was found between vascular endothelial function and sleep status.
Results date posted	2021 Year 07 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with ischemic heart disease who are being treated for arteriosclerosis risk factors such as hypertension, dyslipidemia, and diabetes
Participant flow	Informed consent is given in the explanatory document. We measured vascular endothelial function and asked about sleep status using a questionnaire. Participants participate in the research only once.
Adverse events	none
Outcome measures	Vascular endothelial function sleep status
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Date of IRB	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 01 Month 06 Day
Last follow-up date	2016 Year 12 Month 31 Day
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	2022 Year 07 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029611