UMIN-CTR Clinical Trial

Basic information
Public title	Keio interhospital Cardiovascular Studies - Atrial Fibrillation Registry
Acronym	KiCS AF Registry
Scientific Title	Keio interhospital Cardiovascular Studies - Atrial Fibrillation Registry
Scientific Title:Acronym	KiCS AF Registry
Region	Japan

Condition
Condition	Atrial Fibrillation, Stroke
Classification by specialty	Medicine in general Cardiology Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical characteristics, management pattern, and quality of life under a standardized questionnaire in patients with atrial fibrillation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Death (all-cause death, cardiovascular death, non-cardiovascular death) 2. Stroke (ischemic, hemorrhagic, unknown) 3. Systemic embolism 4. Major bleeding, non-major bleeding with specific healthcare provider responses 5. Major adverse cardiovascular event (acute myocardial infarction, unstable angina, undergoing percutaneous coronary intervention, heart failure)
Key secondary outcomes	Quality-of-life measured by the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients with diagnosis of atrial fibrillation patients (diagnosed or referred within 6 months).
Key exclusion criteria	1. Patients who were not able to give consent 2. Younger than 20 years old 3. Patients who are considered inappropriate to participate in the study by the treating physician.
Target sample size	3333

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Fukuda
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Zip code	160-8582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5843-6702
Email	kfukuda@a2.keio.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Ikemura
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Zip code	160-8582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5843-6702
Homepage URL
Email	ikemu0129@keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Cardiology
Institute
Department

Funding Source
Organization	Bayer Yakuhin MHLW(JAPAN)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University, School of medicine, Independent Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院(東京都) 独立行政法人 国立病院機構 東京医療センター(東京都) 国家公務員 共済組合連合会 立川病院(東京都) 北里研究所病院(東京都) 独立行政法人 国立病院機構 埼玉病院(埼玉県) 日野市立病院(埼玉県) 横浜市立市民病院(埼玉県) さいたま市立病院(埼玉県) 神奈川県警友会けいゆう病院(神奈川県) 済生会宇都宮病院(栃木県) 東京歯科大学市川総合病院(千葉県)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 08 Day

Related information
URL releasing protocol	https://bmjopen.bmj.com/content/9/12/e032746
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	3333
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	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 20 Day
Date of IRB	2012 Year 04 Month 20 Day
Anticipated trial start date	2012 Year 09 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	We plan to present clinically important outcomes with statistical adjustment.

Management information
Registered date	2016 Year 05 Month 06 Day
Last modified on	2020 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025601