UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008018 |
|---|---|
| Receipt number | R000009430 |
| Scientific Title | Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2016/06/23 11:31:08 |
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Basic information
Public title
Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope
Acronym
Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope
Scientific Title
Autonomic and Electrocardiographic Tests Study for Diagnosis in Patients with Syncope
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Yosuke Miwa |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka. Tokyo, Japan
TEL
+81-422-47-5511
y-miwa@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Miwa |
Organization
Arrythmia Center
Division name
Department of Cardiology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
+81-422-47-5511
Homepage URL
y-miwa@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009430
