UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044366 |
|---|---|
| Receipt number | R000050678 |
| Scientific Title | CRYPTOgenic stroke evaluation in Nippon using Insertable Cardiac Monitor |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2025/12/02 19:20:05 |
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Basic information
Public title
CRYPTOgenic stroke evaluation in Nippon using Insertable Cardiac Monitor
Acronym
CRYPTON-ICM
Scientific Title
CRYPTOgenic stroke evaluation in Nippon using Insertable Cardiac Monitor
Scientific Title:Acronym
CRYPTON-ICM
Region
| Japan |
Condition
Condition
Cryptogenic Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the factors associated with atrial fibrillation detection in patients with cryptogenic stroke.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between atrial fibrillation detection and stroke recurrence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Atrial fibrillation detection through insertable cardiac monitoring
Key secondary outcomes
Days from insertable cardiac monitoring implantation to atrial fibrillation detection, atrial fibrillation burden, and stroke recurrence
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
(1) cryptogenic stroke
(2) insertable cardiac monirotoring implantation
(3) follow-up lasting 90 days or more after insertable cardiac monitoring implantation
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Todo |
Organization
Osaka University Graduate School of Medicine
Division name
Departmen of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
ktodo@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Todo |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
Homepage URL
ktodo@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2021 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38240210/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38240210/
Number of participants that the trial has enrolled
417
Results
The detection rate of atrial fibrillation was high in the top 3 BNP quartiles.
The detection rate of atrial fibrillation increased stepwise with higher PAC values.
Atrial fibrillation detection rate was higher with higher PTFV1 values.
Atrial fibrillation detection rate increased with higher left intracardiac blood flow velocity.
There was no association between atrial fibrillation detection and recurrent stroke.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with cryptogenic stroke who underwent ICM implantation at 8 stroke centers in Japan.
Participant flow
The inclusion criteria for this study were as follows: (1) patients diagnosed with cryptogenic stroke according to the Trial of Org 10 172 in Acute Stroke Treatment criteria14 and (2) patients who underwent ICM implantation for AF detection between October 2016 and September 2020.
Adverse events
None
Outcome measures
Incidence of stroke recurrence
Atrial fibrillation detection
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 05 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
A retrospective, observational registry enrolling consecutive patients with insertable cardiac monitoring implantation for cryptogenic stroke through 8 stroke centers in Japan
Management information
Registered date
| 2021 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050678
