UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope
Title of the study (Brief title)	Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope
Region	Japan

Condition
Condition	Syncope
Classification by specialty	Medicine in general Cardiology Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate diagnostic utility and utility of risk-stratification for traffic accident using autonomic and electrocardiographic tests in patients with syncope
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	syncope, presyncope
Key secondary outcomes	arrhythmic events, syncope/presyncope during driving

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Study subjects are patients with myocardial infarction, coronary spastic angina, idiopathic cardiomyopathy and pulmonary hypertension, who are stable disease condition, and are suspected as cardiogenic, vasogenic and neurally mediated syncope. Control subjects are healthy volunteers.
Key exclusion criteria	Exclusion criteria are: unstable disease condition; other cause of syncope as like traumatic or neurological syncope, or hypoglycemia; patients who do not not accept study enrollment or are difficult to follow-up their clinical course.
Target sample size	250

Research contact person
Name of lead principal investigator	Yosuke Miwa
Organization	Kyorin University School of Medicine
Division name	Second Department of Internal Medicine
Address	6-20-2 Shinkawa, Mitaka. Tokyo, Japan
TEL	+81-422-47-5511
Email	y-miwa@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Yosuke Miwa
Organization	Arrythmia Center
Division name	Department of Cardiology
Address	6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL	+81-422-47-5511
Homepage URL
Email	y-miwa@ks.kyorin-u.ac.jp

Sponsor
Institute	Second Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Mutual Insurance Federation of Agricultural Cooperatives
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	The Promotion of Mutual Aid Corporation for Private Schools of Japan

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	杏林大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 05 Month 18 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study

Management information
Registered date	2012 Year 05 Month 23 Day
Last modified on	2016 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009430