UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017612 |
|---|---|
| Receipt number | R000020413 |
| Scientific Title | The relationship between coronary artery disease and muscle sympathetic nerve activity of sleep apnea syndrome patients. |
| Date of disclosure of the study information | 2015/05/18 |
| Last modified on | 2020/11/21 02:36:17 |
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Basic information
Public title
The relationship between coronary artery disease and muscle sympathetic nerve activity of sleep apnea syndrome patients.
Acronym
Sleep apnea syndrome and coronary artery disease.
Scientific Title
The relationship between coronary artery disease and muscle sympathetic nerve activity of sleep apnea syndrome patients.
Scientific Title:Acronym
Sleep apnea syndrome and coronary artery disease.
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep apnea syndrome (SAS) is known as a risk factor of cardio vascular diseases. As to coronary artery disease, SAS is said to be one of the independent risk factor. On the other hand, augmented sympathetic nerve activity in SAS patients was associated with worsening disease. And sympathetic nerve activity is able to be measured by direct recording of muscle sympathetic nerve activity(MSNA). So we performe a retrospective study to elucidate the correlation between single and multiunit MSNA and apnea hypopnea index (AHI) in SAS patients. Subsequently, we try to clarify the correlation of this results and prevalence of coronary artery diseases.
Basic objectives2
Others
Basic objectives -Others
We assume relationship between the severity of sleep apnea syndrome(SAS), sympathetic nerve activity and prevalence of coronary artery disease, using muscle sympathetic nerve activity, full polysomnography and coronary CT, which were already recorded.
The purpose is to crarify the therapeutic target of SAS patient in order to avoid coronary artery disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between apnea hypopnea index, muscle sympathetic nerve activity and prevalence of coronary artery disease.
Key secondary outcomes
Correlation between apnea hypopnea index, single-unit muscle sympathetic nerve activity(MSNA) and multiunit MSNA.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as sleep apnea syndrome
2. Measured evaluable muscle sympathetic nerve activity
3. Measured coronary CT
Key exclusion criteria
1. Received revascularization of coronary artery before measurement of coronary CT
2. Reduced left ventricular ejection fraction(<55%)
3. Heart failure
4. Severe renal dysfunction(estimated glomerulus filtration rate <30ml/min/1.73m2)
5. Refused using their data
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Graduate School of Medical Science, Division of Environmental Science
Division name
Disease Control and Homeostasis
Zip code
Address
Takaramachi13-1, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2000
tokuta114@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuto Hamaoka |
Organization
Kanazawa University Graduate School of Medical Science, Division of Environmental Science
Division name
Disease Control and Homeostasis
Zip code
Address
Takaramachi13-1, Kanazawa City, Ishikawa Prefecture
TEL
076-245-2600
Homepage URL
tokuta114@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Institute
Department
Personal name
Funding Source
Organization
Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kanazawa Municipal Hospital
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
金沢大学附属病院(石川県)、金沢市立病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe time course of single,multiunit muscle sympathetic nerve activity and apnea hypopnea index of sleep apnea syndrome patients. Subsequently we assess relationship of these results and prevalence of coronary artery disease, using coronary CT.
Management information
Registered date
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020413
