Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

Ischemic Stroke Clinical Trial

Official title:

Prognostic Value of Carotid Contrast-Enhanced Ultrasound in Acute Ischemic Stroke Patients for Cerebrovascular and Cardiovascular Event

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03283306
• Other study ID #: B-1607-356-304
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 12, 2017
• Start date: August 9, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2017
• Source: Seoul National University Hospital
• Contact: Yeo Koon Kim, MD
• Phone: 82-10-3460-0660
• Email: yeokoon[@]snubh.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 667
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke
• Ultrasonography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: ? a history of typical angina pain. ? Elevation of Troponin, ? Newly developed ST change or Q waves or LBBB on ECG (outcomes will be measured by chart review or physician diagnosis or telephone interview)	12 months
Secondary	Ipsilateral stroke	Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)	12 months
Secondary	All-cause mortality	All of the deaths, regardless of the cause	12 months
Secondary	Carotid intervention	Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.	12 months