UMIN-CTR Clinical Trial

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	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	Keiichiro Kuronuma
Organization	Nihon University Hospital
Division name	Division of Cardiology
Address	1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	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
Email	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	2018 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

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	2018 Year 12 Month 04 Day
Last modified on	2018 Year 12 Month 04 Day

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
Registered date	File name

Research case data
Registered date	File name

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