UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009992 |
|---|---|
| Receipt number | R000011688 |
| Scientific Title | Multifunction cardiorgram for detection and prognosis of coronary artery disease in comparison with fraction flow reserve |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/03/26 22:55:51 |
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Basic information
Public title
Multifunction cardiorgram for detection and prognosis of coronary artery disease in comparison with fraction flow reserve
Acronym
ifunction cardiorgram for detection and prognosis of coronary artery disease in comparison with fraction flow reserve
Scientific Title
Multifunction cardiorgram for detection and prognosis of coronary artery disease in comparison with fraction flow reserve
Scientific Title:Acronym
ifunction cardiorgram for detection and prognosis of coronary artery disease in comparison with fraction flow reserve
Region
| Japan |
Condition
Condition
patients scheduled for coronary angiography
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess sensitivity and specificity of MultiFunction-Cardiogram for diagnosis of coronary artery disease based on fraction flow reserve
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of MultiFunction-Cardiogram for fraction flow reserve
Key secondary outcomes
Association between MCG and syntax score and functional syntax score
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
| 21 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for coronary angiography
Key exclusion criteria
Patients with CABG, hemodialysis, chronic renal failure, acute myocardial infarction, congestive heart failure, cardiogenic shock, bronchial asthema, elevated pre-procedual cardiac biomarker and whose physitians judge not suitable.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadayuki Uetani |
Organization
Chubu Rosai Hospital
Division name
Cardiology
Zip code
Address
1-10-6, Komei, Minato-ku, Nagoya 465-8530 Japan
TEL
052-652-5511
shinoda.cvm@chubuh.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Shinoda |
Organization
Chubu Rosai Hospital
Division name
Cardiology
Zip code
Address
1-10-6, Komei, Minato-ku, Nagoya 465-8530 Japan
TEL
052-652-5511
Homepage URL
shinoda.cvm@chubuh.rofuku.go.jp
Sponsor or person
Institute
Department of cardiolody, Chubu Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
1
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2015 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011688
