UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035128 |
|---|---|
| Receipt number | R000040038 |
| Scientific Title | Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus |
| Date of disclosure of the study information | 2018/12/04 |
| Last modified on | 2018/12/04 12:09:29 |
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Basic information
Public title
Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus
Acronym
Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus
Scientific Title
Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus
Scientific Title:Acronym
Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify the diagnostic performance of CCT with delayed scanning for the detection of thrombi in the LAA thrombus using delayed scan and to estimate the radiation exposure associated with using 320-detector CCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study was to clarify the diagnostic performance of CCT with delayed scanning for the detection of thrombi in the LAA thrombus using delayed scan and to estimate the radiation exposure associated with using 320-detector CCT.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were scheduled to perform pulmonary vein isolation and underwent TEE and performed Cardiac CT and transesophageal echocardiography.
Key exclusion criteria
Performance of electrical cardioversion, allergy to contrast medium, and uncontrolled bronchial asthma, thyroid disease and/or
chronic kidney disease.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Kuronuma |
Organization
Nihon University Hospital
Division name
Division of Cardiology
Zip code
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
keiichirokuronuma@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Kuronuma |
Organization
Nihon University Hospital
Division name
Division of Cardiology
Zip code
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
keiichirokuronuma@gmail.com
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2018 | Year | 12 | Month | 04 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We enrolled consecutive patients with symptomatic paroxysmal or persistent AF who were scheduled to undergo PVI from August 2016 to May 2017 at Nihon University Hospital.
Management information
Registered date
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040038
| 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 |
