UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058209 |
|---|---|
| Receipt number | R000066549 |
| Scientific Title | Evaluation of the detection of paroxysmal atrial fibrillation by short-term monitoring using an insertable cardiac monitoring in patients with cryptogenic stroke |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/18 13:18:12 |
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Basic information
Public title
Evaluation of short-term monitoring for detecting paroxysmal atrial fibrillation
Acronym
Evaluation of short-term monitoring for detecting paroxysmal atrial fibrillation
Scientific Title
Evaluation of the detection of paroxysmal atrial fibrillation by short-term monitoring using an insertable cardiac monitoring in patients with cryptogenic stroke
Scientific Title:Acronym
Evaluation of the detection of paroxysmal atrial fibrillation by short-term monitoring using an insertable cardiac monitoring in patients with cryptogenic stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the extent to which insertable cardiac monitors detect paroxysmal atrial fibrillation in patients with cryptogenic cerebral infarction at our hospital. It also aims to evaluate the usefulness of short-term (three months to one year) monitoring with these monitors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of paroxysmal atrial fibrillation, stroke incidence rate, patient satisfaction
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study focuses on patients who were diagnosed with cryptogenic stroke at our hospital and fitted with an implantable cardiac monitor.
Key exclusion criteria
1) Patients with a history of atrial fibrillation.
Patients with contraindications or who are unsuitable candidates for long-term oral anticoagulant therapy.
Patients requiring a pacemaker or an implantable cardioverter-defibrillator.
4) Other patients deemed unsuitable for study participation by the attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Doijiri |
Organization
Akita Cerebrospinal and Cardiovascular center
Division name
Cerebrovascular medicine
Zip code
010-0874
Address
6-10 Senshu-Kubota-Machi, Akita
TEL
018-833-0115
doijiri-ryousuke@akita-noken.jp
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawata |
Organization
Akita Cerebrospinal and Cardiovascular center
Division name
Clinical Research Promotion Office
Zip code
010-0874
Address
6-10 Senshu-Kubota-Machi, Akita
TEL
018-833-0115
Homepage URL
kawata@akita-hos.or.jp
Sponsor or person
Institute
Akita Cerebrospinal and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Akita Cerebrospinal and Cardiovascular Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita Cerebrospinal and Cardiovascular Center
Address
6-10 Senshu-kubota-Machi, Akita, 010-0874, JAPAN
Tel
018-833-0115
kawata@akita-hos.or.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
| 2025 | Year | 06 | Month | 18 | 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
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the target patients.
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066549
