UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017000 |
|---|---|
| Receipt number | R000019374 |
| Scientific Title | Role of autonomic nervous system and adrenoceptor gene mutation in Takotsubo Cardiomyopathy |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2015/03/31 20:29:37 |
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Basic information
Public title
Role of autonomic nervous system and adrenoceptor gene mutation in Takotsubo Cardiomyopathy
Acronym
Role of autonomic nervous system and adrenoceptor gene mutation in Takotsubo Cardiomyopathy
Scientific Title
Role of autonomic nervous system and adrenoceptor gene mutation in Takotsubo Cardiomyopathy
Scientific Title:Acronym
Role of autonomic nervous system and adrenoceptor gene mutation in Takotsubo Cardiomyopathy
Region
| Japan |
Condition
Condition
Takotsubo cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Takotsubo cardiomyopathy (TCM), also called broken heart syndrome, is typically reported in the setting of emotional and/or physiological stress. The exact pathophysiology of TCM is poorly understood. Nevertheless altered autonomic nervous regulation, and in consequence, over excretion of catecholamines may play an important role in triggering the syndrome.
Basic objectives2
Others
Basic objectives -Others
We will determine if TCM patients have an excess sympathetic nerve activity and/or overstated sympathetic response to stress compared to healthy subjects. Also we will assess the susceptibility of having an exaggerated sympathetic response to stress upon polymorphisms of the adrenoceptors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is plasma norepinephrine and epinephrine during the stress test between TCM and healthy subjects.
Key secondary outcomes
The secondly outcome is blood pressure, heart rate, indexes of autonomic function test and genetic polymorphisms of adrenoceptors between TCM and control subjects.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We will assess the stress reaction after we perform the standard autonomic function test of participants.
All the medications which might affect the autonomic nervous system were withheld for at least five times the elimination half-life before the studies. Continuous blood pressure (BP) and heart rate (HR) measurements were obtained using an automated oscillometric sphygmomanometer and tonometry (BP-608 Evolution II, Omron Colin Corporation). An antecubital vein will be cannulated for blood sampling of plasma catecholamines and cortisol before and after stress loading tests, namely speech test and mental calculation test. Continuous HR and BP during the tests will be recorded. The order of mental calculation test and speech test will be randomized to avoid order effect.
Subjects will be asked to begin with 1000 and count backward by 17 as much as they can for 3 minutes (eg. 1000-17=983, 983-17=966, ...).
The theme of the speech test will be chosen by each subjects from the following; self introduction, a funny story of recent or a touching tale. They will speech in front of the medical profession(s) for 3 minutes.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. Definition criteria of TCM
1. Transient hypokinesis, akinesis, or dyskinesis of the left ventricular midsegments with or without apical involvement; the regional wall motion abnormalities extend beyond a single epicardial vascular distribution; a stressful trigger is often, but not always present.
2. Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture.
3. New electrocardiographic abnormal-
ities (either ST-segment elevation and/or T-wave inversion) or modest elevation of cardiac troponin.
4. Absence of:recent significant head trauma, intracranial bleeding, pheochromocytoma, myocarditis, hypertrophic cardiomyopathy.
B. Subjects inclusion criteria
1. Age >= 20 years old.
2. TCM patietns: History of TCM more than the prior 3 weeks with well-preserved general condition.
3. Healthy subjects: Matched by a comparable age and sex of TCM patients.
Key exclusion criteria
1. Patients who have uncontrolled cardiovascular diseases such as congestive heart failure, ischemic heart disease, hypertension, arrhythmia
2. Patients who have uncontrolled diabetes meltis
3. Pregnant or lactating women
4. Patients who have overt concomitant disease
5. Patients who are not eligible for this study by study doctors
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sakura |
Organization
Tokyo Women's Medical University, East Medical Center
Division name
Department of Medicine
Zip code
Address
2-1-10 Nishiogu, Arakawa, Tokyo, 116-8567
TEL
03-3810-1111
sakuragm@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Sato |
Organization
Tokyo Women's Medical University, East Medical Center
Division name
Department of Medicine
Zip code
Address
2-1-10 Nishiogu, Arakawa, Tokyo, 116-8567
TEL
03-3810-1111
Homepage URL
satokgm@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokai University
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
東京女子医科大学東医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | 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
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019374
