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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048536
Receipt No. R000054975
Scientific Title Regular pulse check for patients with non-cardioembolic stroke in rehabilitation hospital to improve recognition and detection of atrial fibrillation
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/01

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Basic information
Public title Regular pulse check for patients with non-cardioembolic stroke in rehabilitation hospital to improve recognition and detection of atrial fibrillation
Acronym Pulse check for detection of atrial fibrillation detection
Scientific Title Regular pulse check for patients with non-cardioembolic stroke in rehabilitation hospital to improve recognition and detection of atrial fibrillation
Scientific Title:Acronym ESCORT study
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 After diagnosis and treatment are completed at an acute care hospital, patients are promptly transferred to a recovery-phase rehabilitation hospital for functional recovery. Upon transfer, there is currently little or no attempt to detect atrial fibrillation. In addition, it is believed that therapists actually in charge of rehabilitation have insufficient awareness of the possibility that patients in their charge may have undiagnosed atrial fibrillation and of the importance of atrial fibrillation detection. In this study, we would like to deepen the understanding of the importance of AF detection among therapists in rehabilitation hospitals and examine whether regular pulse screening can contribute to the detection of AF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of atrial fibrillation detection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Pulse check
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 non-cardioembolic stroke
Key exclusion criteria 1) Patients currently participating or planning to participate in an interventional trial
2) Patients with a history of atrial fibrillation or atrial flutter
3) Patients diagnosed with a life expectancy of 1 year or less due to any disease
4) Other patients who are judged by the investigator to be inappropriate to participate in the study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Suda
Organization Nippon Medical School
Division name Department of Neurology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email suda-sa@nms.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Suda
Organization Nippon Medical School
Division name Department of Neurology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email suda-sa@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Pfizer Co.
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 Nippon Medical School
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel 03-3822-2131
Email nms_rinri@nms.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
2022 Year 08 Month 02 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 Enrolling by invitation
Date of protocol fixation
2022 Year 08 Month 01 Day
Date of IRB
2021 Year 09 Month 28 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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