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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010528
Receipt No. R000012299
Scientific Title Multifunction cardiogram Evaluation in Diagnosis of Functional coronary Ischemia sTudy
Date of disclosure of the study information 2013/04/17
Last modified on 2014/04/21

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Basic information
Public title Multifunction cardiogram Evaluation in Diagnosis of Functional coronary Ischemia sTudy
Acronym MED-FIT
Scientific Title Multifunction cardiogram Evaluation in Diagnosis of Functional coronary Ischemia sTudy
Scientific Title:Acronym MED-FIT
Region
Japan

Condition
Condition Ischemic Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of MultiFunction-CardioGram in diagnosis of ischemic heart disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase IV

Assessment
Primary outcomes correlation between severity score in MutiFunction-CardioGram with functional myocardial ischemia.
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 adult patients scheduled for coronary angiography
Key exclusion criteria HD, CTO, OMI, medication (be-ta blocker, Nitrast)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin, Sakyoku, Kyoto city, Kyoto prefecture
TEL 0757513111
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuma Kawaji
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin, Sakyoku, Kyoto city, Kyoto prefecture
TEL 0757513111
Homepage URL
Email kawaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization TORAY medical Co.Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2013 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 12 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2014 Year 04 Month 12 Day

Other
Other related information After registration, evaluate correlation between MCG severity score and functional myocardial ischemia

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2014 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012299

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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