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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035177
Receipt No. R000040090
Scientific Title International Prospective Registry Study of Patients with Microvascular Angina
Date of disclosure of the study information 2018/12/08
Last modified on 2018/12/08

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Basic information
Public title International Prospective Registry Study of Patients with Microvascular Angina
Acronym International Prospective Registry Study of Patients with Microvascular Angina
Scientific Title International Prospective Registry Study of Patients with Microvascular Angina
Scientific Title:Acronym International Prospective Registry Study of Patients with Microvascular Angina
Region
Japan North America Australia
Europe

Condition
Condition Microvascular Angina
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This international collaborative study aims to elucidate the risk factors, clinical features, diagnostic methods, treatments and prognosis of patients with MVA on exactly the same basis.
Basic objectives2 Others
Basic objectives -Others This international collaborative study aims to elucidate the risk factors, clinical features, diagnostic methods, treatments and prognosis of patients with MVA on exactly the same basis.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes A composite endpoint will include cardiovascular death, fatal AMI, hospitalization for heart failure, arrhythmia, stroke, and hospitalization for unstable angina. Events will be analyzed as time from enrolment to first occurrence of any event from the composite endpoint.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with microvascular angina (MVA). In the present study, MVA is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries.
Key exclusion criteria None
Target sample size 500

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, Miyagi
TEL 022-717-7153
Email shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Suda
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7153
Homepage URL http://csa.cardiovascular-medicine.jp
Email akira5885@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japanese Coronary Spasm Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 08 Day

Related information
URL releasing protocol http://csa.cardiovascular-medicine.jp/about/index.html
Publication of results Unpublished

Result
URL related to results and publications http://csa.cardiovascular-medicine.jp/about/index.html
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
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Coronary Vasomotor Disorder Study Group (COVADIS)
COVADIS was formed in 2013 and currently consists of 8 institutes in the world. It aims to conduct researches on the pathophysiology regarding the coronary circulation.
The Steering Committee of COVADIS will consist of the principal investigators from each of geographic international sites and the DCC, and the overall study co-chairpersons. The Steering Committee members are as follows: C. Noel Bairey Merz, MD (Study co-chair, USA), John Beltrame, MBBS (Study co-chair, Australia), Hiro Shimokawa MD (PI, DCC, Japan), Hisao Ogawa MD (PI, Japan), Udo Sechtem (PI, Germany), Peter Ong (PI, Germany), Juan Carlos Kaski (PI, United Kingdom), Filippo Crea (PI, Italy), and Paolo Camici (PI, Italy). From time to time, some other investigators or consultants may be asked to serve as ex-officio members.
The Steering Committee will operate in a consensus mode relative to the formulation of all policy and publication decisions. The Steering Committee will meet regularly to review the status of study policy and publications. A summary of these meetings will be recorded by a Steering Committee member or designee. These summaries will be distributed to members of the Steering Committee in advance for review and approval at the next Committee meeting. Upon approval, these summaries will constitute part of the permanent record of the COVADIS project maintained by the co-chairs.

Management information
Registered date
2018 Year 12 Month 08 Day
Last modified on
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040090

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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