UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051042 |
|---|---|
| Receipt number | R000058184 |
| Scientific Title | Contrast-enhanced computed tomography of the venous phase, not the arterial phase, is essential for the evaluation of the right phrenic nerve |
| Date of disclosure of the study information | 2023/05/11 |
| Last modified on | 2023/05/11 21:01:32 |
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Basic information
Public title
Contrast-enhanced computed tomography of the venous phase, not the arterial phase, is essential for the evaluation of the right phrenic nerve
Acronym
Visualization of right PBs using CT
Scientific Title
Contrast-enhanced computed tomography of the venous phase, not the arterial phase, is essential for the evaluation of the right phrenic nerve
Scientific Title:Acronym
Visualization of right PBs using CT
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the ability to detect the right pericardiophrenic bundles using the venous as well as arterial phases of contrast-enhanced CT and to ascertain whether three-dimensional reconstruction of pericardiophrenic bundles from CT data could locate the running course of the PN detected by electrical phrenic pace map. Furthermore, we investigated what factors influence the detection of right pericardiophrenic bundles on contrast-enhanced CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ability to detect the right pericardiophrenic bundles using the venous as well as arterial phases of contrast-enhanced CT.
To ascertain whether three-dimensional reconstruction of pericardiophrenic bundles from CT data could locate the running course of the PN detected by electrical phrenic pace map.
What factors influence the detection of right pericardiophrenic bundles on contrast-enhanced CT?
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included patients with AF who underwent AF ablation and preprocedural contrast-enhanced CT.
Key exclusion criteria
The patients who did not undergo contrast-enhanced CT because of contrast agent allergy and/or chronic kidney disease, and missing data regarding the venous phase of contrast-enhanced CT before catheter ablation were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tada |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
+81-776-61-8800
daisetsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
+81-776-61-8800
Homepage URL
daisetsu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
+81-776-61-8800
daisetsu@u-fukui.ac.jp
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
| 2023 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058184
| Research Plan | |
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| 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 |
