UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020606
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.