UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010528 |
|---|---|
| Receipt number | 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 17:28:27 |
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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
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
kawaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012299
| 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 |
