UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048536 |
|---|---|
| Receipt number | 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 11:36:23 |
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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
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
suda-sa@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
