Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

NCT ID: NCT03283306

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-09

Study Completion Date

2020-09-30

Brief Summary

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Contrast-enhanced ultrasound(CEUS) of carotid artery plaque is a novel method that enabled direct visualization of neovessels in the vulnerable plaque. Plaque enhancement with CEUS showed correlation with the histologic density of neovessels within the carotid plaque and the previous cardiovascular events. Vulnerable plaques with a high risk of thromboembolic complications and rapid progression is associated with acute ischemic stroke. The prognostic value of vulnerable carotid artery plaque depicted with CEUS has not been fully investigated. The purpose of this study is to define prognostic value of plaque enhancement on carotid CEUS in acute stroke patients. Research question is; in acute ischemic stroke patients with ipsilateral carotid plaque as probable etiology of stroke, is the presence of carotid plaque enhancement on CEUS independent predictor of future stroke.

Detailed Description

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Conditions

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Ultrasonography Carotid Stenosis Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients older than 19 years presenting acute ischemic stroke.
2. Compatible neurologic symptom within 14 days
3. Compatible MRI finding (one or more positive DWI lesions in the territory of unilateral ICA: ACA or MCA territory) - interpretable MRI image obtained in SNUBH or outside hospital
4. Etiology of acute ischemic stroke: except cardioembolic stroke (Atrial fibrillation) and other determined etiology
5. Ipsilateral extracranial carotid artery stenosis on MRA (CE-MRA), CTA or Doppler ultrasound

Exclusion Criteria

1. History of ipsilateral carotid stent or endarterectomy
2. Carotid intervention during hospital stay
3. Contraindication to ultrasound contrast agent (SonoVue) A. Right to left, bi-directional, or transient right to left cardiac shunts B. History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or any ultrasound contrast agent C. Pregnant or lactating woman D. Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening congestive heart failure, or serious ventricular arrhythmias)
4. Expected life span less than 12 months
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yeo Koon Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeo Koon Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeo Koon Kim, MD

Role: CONTACT

82-10-3460-0660

Eun Jung Kim

Role: CONTACT

82-10-2450-3988

Facility Contacts

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Yumi Kim

Role: primary

+82-31-787-8872

Other Identifiers

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B-1607-356-304

Identifier Type: -

Identifier Source: org_study_id

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