Carotid Stenosis, Ischemic Stroke, Ultrasonography
Conditions
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.
Interventions
None listed
Sponsors
National Research Foundation of Korea
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of recurrent stroke, vascular death and myocardial infarction | 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
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral stroke | 12 months | Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction) |
| All-cause mortality | 12 months | All of the deaths, regardless of the cause |
| Carotid intervention | 12 months | Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge. |
Countries
South Korea
Contacts
Primary ContactYeo Koon Kim, MD
Backup ContactEun Jung Kim
Outcome results
None listed