UMIN-CTR Clinical Trial

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

Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017612
Receipt No. 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

* 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 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
Email 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
Email tokuta114@yahoo.co.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020413

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.