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Status unknownNCT03283306Updated Sep 14, 2017

Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

An observational study in Ultrasonography, Carotid Stenosis and Ischemic Stroke, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
667
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ultrasonography
  • Carotid Stenosis
  • Ischemic Stroke
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
667 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Composite of recurrent stroke, vascular death and myocardial infarction

    (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)

    Time frame: 12 months

Secondary outcomes

  1. Ipsilateral stroke

    Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)

    Time frame: 12 months

  2. All-cause mortality

    All of the deaths, regardless of the cause

    Time frame: 12 months

  3. Carotid intervention

    Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03283306
Lead sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea, Seoul National University Bundang Hospital
Responsible party
Yeo Koon Kim (Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 14, 2017
Start date
Aug 9, 2017
Primary completion
Sep 30, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Sep 14, 2017

Study contacts

Yeo Koon Kim, MD
Contact
yeokoon@snubh.org
82-10-3460-0660
Eun Jung Kim
Contact
jfhg92@naver.com
82-10-2450-3988
Yeo Koon Kim, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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