UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016146 |
|---|---|
| Receipt number | R000018270 |
| Scientific Title | Clinical Course of Patients with Atrial Fibrillation during Non-cardiac Perioperative Period |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2020/07/13 14:05:54 |
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Basic information
Public title
Clinical Course of Patients with Atrial Fibrillation during Non-cardiac Perioperative Period
Acronym
Clinical Course of Patients with Atrial Fibrillation during Non-cardiac Perioperative Period
Scientific Title
Clinical Course of Patients with Atrial Fibrillation during Non-cardiac Perioperative Period
Scientific Title:Acronym
Clinical Course of Patients with Atrial Fibrillation during Non-cardiac Perioperative Period
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Oto-rhino-laryngology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To survey the annual recurrence rate of atrial fibrillation and the incidece rate of stroke event in patients newly diagnosed as atrial fibrillation during non-cardiac perioperative period
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence rate and risk factor for atrial fibrillation during non-cardiac perioperative period
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual reccurrence rate of atrial fibrillation post perioperative period in patients newly diagnosed.
Key secondary outcomes
1. The incident rate of embolic event within 30 days after surgery.
2. The annual incident rate of embolic event in atrial fibrillation v.s. non-atrial fibrillation groups.
3. The annual mortality rate in atrial fibrillation v.s. non-atrial fibrillation groups.
4. 5-years incident rate of atrial fibrillation and embolic event.
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
Patients with plan for surgery under general anesthesia due to suspected malignancy.
Key exclusion criteria
Patients with persistent or chronic atrial fibrillation.
Patients without informed consent.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Kyorin University Hospital
Division name
Department of Cardiology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
satoshi_hgc@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Kyorin University Hospital
Division name
Department of Cardiology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
Homepage URL
satoshi_hgc@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI: Grant Number 17K18085
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine
Address
Shinkawa
Tel
0422475511
irb@ks.kyorin-u.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
| 2015 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-018-0862-9
Publication of results
Partially published
Result
URL related to results and publications
https://www.onlinecjc.ca/article/S0828-282X(19)30479-9/fulltext
Number of participants that the trial has enrolled
752
Results
Of 752 consecutive patients, 77 (10.2%) developed POAF and wore an event recorder for 19 (12-30) days. AF and ischemic stroke at 1 year were observed in 24 patients (31.1%) and 2 patients (2.6%) with POAF and 4 patients (0.6%) and 3 patients (0.4%) without POAF, respectively. Of the 24 patients with POAF and AF recurrence, 22 (92%) were asymptomatic.
Results date posted
| 2020 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study.
At first, we investigate the incidence rate of atrial fibrillation(AF), embolic event rate, and mortality during non-cardiac perioperative period and examine the related factors for development of AF. Secondly, we follow up the patients who were newly diagnosed as AF to study the subsequent recurrence rate of AF and incident rate of embolism.
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2020 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018270
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| Registered date | File name |
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