Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

• Conditions: Ischemic Stroke; Carotid Stenosis; Ultrasonography

• Registration Number: NCT03283306
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Status Verified: 2017-09
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 667

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality	12 months	All of the deaths, regardless of the cause
Ipsilateral stroke	12 months	Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)
Carotid intervention	12 months	Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of