UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016146
Receipt No. 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 (Ver. 10)

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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
Email 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
Email satoshi_hgc@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018270