UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003304 |
|---|---|
| Receipt number | R000003998 |
| Scientific Title | Prospective multi-center registry study of patients with vasospastic angina |
| Date of disclosure of the study information | 2010/03/09 |
| Last modified on | 2010/03/09 14:07:23 |
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Basic information
Public title
Prospective multi-center registry study of patients with vasospastic angina
Acronym
International Study on Vasospastic Angina
Scientific Title
Prospective multi-center registry study of patients with vasospastic angina
Scientific Title:Acronym
International Study on Vasospastic Angina
Region
| Japan | Asia(except Japan) | Australia |
| Europe |
Condition
Condition
vasospastic angina
microvascular angina
Takotsubo cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this international multicenter prospective registry study is elucidate the clinical characteristics, diagnosis, treatment and prognosis in patients with vasospastic angina diagnosed on the basis Japanese Circulation Society Guideline 2008. This study also will investigate the diseases associated with vasospastic angina, that is, microvascular angina and Takotsubo cardiomyopathy.
Basic objectives2
Others
Basic objectives -Others
patient outcome in the real world practice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac event
Key secondary outcomes
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
Vasospastic angina- 1. an angina attack at rest or on effort, accompanied by a more than 0.1 mV ST segment elevation or depression or a negative U wave at least 2 related ECG leads and/or 2. total or subtotal coronary artery occlusion (over 90% stenosis) during the provocation test accompanied by chest pain and/or ischemic ECG changes (on the basis of Japanese Circulation Society Guideline 2008).
Microvascular angina- a condition defined by the presence of angina-like chest pain, a positive response to stress ECG finding and normal coronary angiography
Takotsubo cardiomyopathy- 1. Onset with symptoms suspicious of acute myocardial infarction and with ST segment elevation in the electrocardiogram, T-wave inversion (giant negative T-wave), QT prolongation 2. Apical ballooning with akinesis and basal hyperkinesis 3. Lack of significant coronary artery stenosis.
Key exclusion criteria
Patients who did not give informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, JAPAN
TEL
022-717-7153
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yasuda |
Organization
Japanese Coronary Spasm Association
Division name
Secretary Office
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, JAPAN
TEL
022-717-7153
Homepage URL
http://csa.cardiovascular-medicine.jp/
csa@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japanese Coronary Spasm Association
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 09 | 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
| 2010 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
Multicenter registry study with prospective fashion
Registration of all patients with informed consent
Management information
Registered date
| 2010 | Year | 03 | Month | 09 | Day |
Last modified on
| 2010 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
