UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025736 |
|---|---|
| Receipt number | 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 | 2022/07/25 10:00:54 |
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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
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
ihd.prevention@gmail.com
Sponsor or person
Institute
Department of Clinical Laboratory, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
