UMIN-CTR Clinical Trial

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