UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020413