UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050627 |
|---|---|
| Receipt number | R000057671 |
| Scientific Title | Observational study of relationship between postoperative atrial fibrillation and pulmonary vein left atrium anatomy |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2023/03/18 17:18:20 |
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Basic information
Public title
Observational study of relationship between postoperative atrial fibrillation and pulmonary vein left atrium anatomy
Acronym
Observational study of relationship between postoperative atrial fibrillation and pulmonary vein left atrium anatomy
Scientific Title
Observational study of relationship between postoperative atrial fibrillation and pulmonary vein left atrium anatomy
Scientific Title:Acronym
Observational study of relationship between postoperative atrial fibrillation and pulmonary vein left atrium anatomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Cardiology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between postoperative atrial fibrillation and the pulmonary vein, left atrium anatomy.
Basic objectives2
Others
Basic objectives -Others
Event of postoperative atrial fibrillation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictor of postoperative atrial fibrillation
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Esophageal cancer
2. After Esophagectomy
Key exclusion criteria
1. History of atrial fibrillation
2. Atrial flutter rhythm
3. History of pacemaker implantation
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kashiwagi |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
mkashi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kashiwagi |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
mkashi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 03 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Postoperative atrial fibrillation
Operation method and result
Echocardiographic result
Enhanced computed tomography image
Age, sex, height, weight
History of diabetes mellitus, hypertension, dyslipidemia, smoking, alcohol, heart disease and medication
Electrocardiogram
Prognosis
Management information
Registered date
| 2023 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057671
