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Trial record 35 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

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ClinicalTrials.gov Identifier: NCT03283306
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
National Research Foundation of Korea
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Yeo Koon Kim, Seoul National University Hospital

Brief Summary:
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.

Condition or disease
Ultrasonography Carotid Stenosis Ischemic Stroke

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 667 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prognostic Value of Carotid Contrast-Enhanced Ultrasound in Acute Ischemic Stroke Patients for Cerebrovascular and Cardiovascular Event
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020



Primary Outcome Measures :
  1. Composite of recurrent stroke, vascular death and myocardial infarction [ Time Frame: 12 months ]
    (1) recurrent stroke: newly appeared DWI positive lesion on brain MRI with corresponding neurologic symptom (2) vascular death: sudden death, death due to stroke, myocardial infarction, heart failure, arrhythmia, pulmonary embolism, systemic bleeding, or ischemia of organ. (3) myocardial infarction: at least two of the followings: ① a history of typical angina pain. ② Elevation of Troponin, ③ Newly developed ST change or Q waves or LBBB on ECG (outcomes will be measured by chart review or physician diagnosis or telephone interview)


Secondary Outcome Measures :
  1. Ipsilateral stroke [ Time Frame: 12 months ]
    Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)

  2. All-cause mortality [ Time Frame: 12 months ]
    All of the deaths, regardless of the cause

  3. Carotid intervention [ Time Frame: 12 months ]
    Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283306


Contacts
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Contact: Yeo Koon Kim, MD 82-10-3460-0660 yeokoon@snubh.org
Contact: Eun Jung Kim 82-10-2450-3988 jfhg92@naver.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Yumi Kim    +82-31-787-8872    98716@snubh.org   
Sponsors and Collaborators
Seoul National University Hospital
National Research Foundation of Korea
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Yeo Koon Kim, MD Seoul National University Hospital

Additional Information:

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Responsible Party: Yeo Koon Kim, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03283306     History of Changes
Other Study ID Numbers: B-1607-356-304
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Carotid Artery Diseases
Arterial Occlusive Diseases