UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022229 |
|---|---|
| Receipt number | R000025601 |
| Scientific Title | Keio interhospital Cardiovascular Studies - Atrial Fibrillation Registry |
| Date of disclosure of the study information | 2016/05/08 |
| Last modified on | 2020/04/30 12:28:44 |
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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
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
ikemu0129@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025601
