UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054818 |
|---|---|
| Receipt number | R000062616 |
| Scientific Title | Clarification of Aortogenic Stroke by Non-Obstructive General Angioscopy |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/28 23:28:34 |
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Basic information
Public title
Clarification of Aortogenic Stroke by Non-Obstructive General Angioscopy
Acronym
CRYSTAL Trial
Scientific Title
Clarification of Aortogenic Stroke by Non-Obstructive General Angioscopy
Scientific Title:Acronym
CRYSTAL Trial
Region
| Japan |
Condition
Condition
cerebral infraction
Classification by specialty
| Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to elucidate the mechanisms of Embolic Stroke of Undetermined Source (ESUS). During mechanical thrombectomy in the acute phase of cerebral infarction, screening for aortic-origin cerebral infarction will be conducted using intravascular endoscopy. Additionally, transesophageal echocardiography will be performed promptly in the perioperative period. Furthermore, pathological examinations will be conducted on retrieved thrombi and naturally expelled aortic plaque debris. A series of tests to search for the embolic source of cerebral infarction will be performed both prospectively and retrospectively (through chart reviews).
Basic objectives2
Others
Basic objectives -Others
Utilizing transesophageal echocardiography (TEE) and other advanced diagnostic methods, we aim to achieve a more definitive diagnosis of ESUS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we made definitive diagnoses for thrombectomy cases, excluding those with atherothrombotic brain infarction, through discussions with the brain-heart team (BHT). With the cooperation of intravascular endoscopy and the brain-heart team (BHT), it has become possible to classify cases that were previously diagnosed as embolic strokes of undetermined source (ESUS), particularly those of aortogenic stroke.
Key secondary outcomes
Using transesophageal echocardiography (TEE), we aim to further stratify ESUS cases and move closer to a definitive diagnosis.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
acute ischemic stroke are assessed by neurologists and neurosurgeons using CT and MRI to diagnose strokes caused by large or medium vessel occlusion
Key exclusion criteria
atherothrombotic brain infarction, aortic dissection, deteriorating condition, not obtained informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
543-0035
Address
10-31 Kitayamacho, Tennoji-Ku, Osaka
TEL
06-6771-6051
yhiguchi.ja@gmail.com
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Shiba |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
543-0035
Address
10-31 Kitayamacho, Tennnoji-Ku, Osaka
TEL
06-6771-6051
Homepage URL
mikio0629@gmail.com
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Police Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee Osaka Police Hospital
Address
10-31 Kitayamacho, Tennoji-Ku, Osaka
Tel
06-6771-6051
shomu@oph.gr.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
| 2024 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients with cerebral infarction are hospitalized and performed emergent mechanical thrombectomy. Excluded atherothrombotic brain infarction, aortic dissection, deteriorating condition, not obtained informed consent, subjects are studied as thrombectomy and angioscopic observation. After that, transesophageal echocardiography will be promptly performed in the perioperative period to assess intracardiac thrombi and patent foramen ovale (PFO). Furthermore, pathology of retrieved thrombi and embolic materials obtained from the periphery of spontaneously ruptured aortic arch plaques will be reviewed. In addition to the standard fixed-stained microscopy, cholesterol crystals within the embolic material are observed under a non-fixed and non-stained state using a polarizing microscope.
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062616
