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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037427
Receipt No. 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 2019/07/19

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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
Email 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
Email kazuy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
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 Open public 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
2019 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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