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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003304
Receipt No. 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

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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
Email

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/
Email csa@cardio.med.tohoku.ac.jp

Sponsor
Institute Japanese Coronary Spasm Association
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003998

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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