UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037427 |
|---|---|
| Receipt number | R000042458 |
| Scientific Title | Stratification by Multidimensional Approach for Rational Treatment of Asymptomatic Carotid Stenosis |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2023/01/20 19:17:49 |
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Basic information
Public title
Stratification by Multidimensional Approach for Rational Treatment of Asymptomatic Carotid Stenosis
Acronym
SMART-K study
Scientific Title
Stratification by Multidimensional Approach for Rational Treatment of Asymptomatic Carotid Stenosis
Scientific Title:Acronym
SMART-K study
Region
| Japan |
Condition
Condition
patients with asymptomatic carotid artery stenosis with MRI-detected intraplaque hemorrhage
Classification by specialty
| Cardiology | Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to clarify the outcomes of medical treatment for asymptomatic carotid artery stenosis with IPH, and to investigate the value of sLOX-1 in predicting high ischemic risk.
Basic objectives2
Others
Basic objectives -Others
The present study aims to clarify the outcomes of medical treatment for asymptomatic carotid artery stenosis with IPH, and to investigate the value of sLOX-1 in predicting high ischemic risk.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
cerebral infarction, transient ischemic attack, or amaurosis fugax resulting from carotid artery stenosis
Key secondary outcomes
any cerebral infarction or any other condition that in the judgment of the attending physician requires revascularization (endarterectomy or stenting)
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
1. Patients with asymptomatic atherosclerotic carotid artery stenosis with area stenosis of more than 60% as diagnosed by carotid artery ultrasonography, and who will be undergoing medical treatment.
2. Patients who have undergone MRI during the course of treatment, and in whom MRI plaque assessment has revealed the presence of IPH.
3. Patients who have provided sufficiently informed consent to participate in the study.
4. Patients who are capable of attending outpatient appointments and are expected to live more than 5 years after enrollment.
Key exclusion criteria
1. Patients who cannot undergo MRI
2. Patients who have previously undergone or are currently receiving radiotherapy to the head and neck region.
3. Patients who have undergone CEA or carotid artery stenting for the carotid artery stenosis concerned.
4. Patients judged by an investigator or subinvestigator to be ineligible for any other reason.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumichi |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto University Graduate School of Medicine
Division name
neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513459
Homepage URL
kazuy@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital, Ethics Committe
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
Tel
0757534680
kazuy@kuhp.kyoto-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
京都大学病院（京都府）、国立循環器病研究センター（大阪府）、北野病院（大阪府）、川崎医科大学（岡山県）、倉敷中央病院（岡山県）、小倉記念病院（福岡県）、高知医療センター（高知県）、九州医療センター（福岡県）、九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
88
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Parameters Investigated
1. At enrollment
Basic data on the following parameters will be collected from medical records and imaging investigations: 1) age and sex; 2) medical history (hypertension: blood pressure over 140/90 mmHg during any examination from the previous 3 months, or taking antihypertensive medication; hypercholesterolemia: LDL cholesterol over 140 mg/dl, or taking lipid-lowering medication; diabetes: hemoglobin A1c over 6.1%, or taking oral blood sugar-lowering medication or insulin; cerebral infarction: diagnosed at a medical institution; ischemic heart disease: identification of coronary artery stenosis over 75%, or previous treatment; atrial fibrillation: diagnosed at a medical institution; valve disease: diagnosed at a medical institution); 3) lifestyle (smoking: previous or current smoker; excessive alcohol consumption: alcohol intake over 150 g/week); 4) blood tests (regular biochemistry tests and sLOX-1 antibody titer); and 5) cranial MRI: including diffusion-weighted imaging and fluid-attenuated inversion recovery imaging; 6) imaging evaluation of carotid artery stenosis (carotid artery ultrasonography, carotid artery MRI).
2. Follow-up investigations
Examinations will be carried out every 6 months, and carotid artery ultrasound and carotid artery MRI every 12 months. Examinations, blood tests, carotid artery ultrasound, carotid artery MRI, and cranial MRI will be carried out until the end of the observation period or an endpoint is reached.
Management information
Registered date
| 2019 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042458
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