UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035177
Receipt number 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 10:48:06

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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 or person

Institute

Department of Cardiovascular Medicine,Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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