UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020606 |
|---|---|
| Receipt number | R000023787 |
| Scientific Title | Study for the reliability of contrast CT image in detection of thrombus in left atrial appendage. |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2017/07/19 09:16:43 |
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Basic information
Public title
Study for the reliability of contrast CT image in detection of thrombus in left atrial appendage.
Acronym
THe Reliability of cOMputed tomography Beyond Ultra Sound in THROMBUS detection(THROMBUS)
Scientific Title
Study for the reliability of contrast CT image in detection of thrombus in left atrial appendage.
Scientific Title:Acronym
THe Reliability of cOMputed tomography Beyond Ultra Sound in THROMBUS detection(THROMBUS)
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reliability of contrast CT image in detection of left atrial appendage thrombosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of contrast defect in left atrial appendage during contrast CT image
Key secondary outcomes
the accuracy of contrast CT compared with transesophageal echocardiography in detection of left atrial appendage thrombus
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
consecutive patients undergoing contrast CT before and after catheter ablation for atrial fibrillation
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
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 Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513111
Homepage URL
kawaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Takeshi Kimura
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2016 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Retrospective and prospective cohort study
Study population: consecutive patients who received and will receive contrast CT image for catheter ablation of atrial fibrillation between January 2014 and December 2015 and between February 2016 and December 2018.
Primary endpoint:
The prevalence of contrast CT image evaluable in left atrial appendage.
Secondary endpoints:
The accuracy of contrast CT image compared with that of transesophageal echocardiography
The difference between before and after innovation of contrast CT image acquisition.
Management information
Registered date
| 2016 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023787
| Research Plan | |
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| 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 |
