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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000035128 |
Receipt No. | R000040038 |
Official scientific title of the study | 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 |
Basic information | ||
Official scientific title of the study | Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus | |
Title of the study (Brief title) | Usefulness of Dual-phase Snapshot 320-detector Computed Tomography for Detection of a Left Atrial Appendage Thrombus | |
Region |
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Condition | ||
Condition | Atrial Fibrillation | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
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Concealment |
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Eligibility | ||||
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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. |
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Target sample size | 90 |
Research contact person | |
Name of lead principal investigator | Keiichiro Kuronuma |
Organization | Nihon University Hospital |
Division name | Division of Cardiology |
Address | 1-6, Kanda Surugadai, Chiyoda-ku, Tokyo |
TEL | 03-3293-1711 |
keiichirokuronuma@gmail.com |
Public contact | |
Name of contact person | Keiichiro Kuronuma |
Organization | Nihon University Hospital |
Division name | Division of Cardiology |
Address | 1-6, Kanda Surugadai, Chiyoda-ku, Tokyo |
TEL | 03-3293-1711 |
Homepage URL | |
keiichirokuronuma@gmail.com |
Sponsor | |
Institute | Nihon University Hospital |
Institute | |
Department |
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) |
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 |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
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 |
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Link to view the page | |
URL(English) | https://upload.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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Research case data | |
Registered date | File name |