UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the reliability of contrast CT image in detection of thrombus in left atrial appendage.
Title of the study (Brief title)	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	Takeshi Kimura
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	0757513111
Email	taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tetsuma Kawaji
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	0757513111
Homepage URL
Email	kawaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Takeshi Kimura
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023787