Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Carotid Stenosis; Ultrasonography

• Study Type: Observational
• Enrollment (Anticipated): 667

Contacts and Locations

• Study Contact: Name: Yeo Koon Kim, MD; Phone Number: 82-10-3460-0660; Email: yeokoon@snubh.org
• Study Contact Backup: Name: Eun Jung Kim; Phone Number: 82-10-2450-3988; Email: jfhg92@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Yumi Kim; Phone Number: +82-31-787-8872; Email: 98716@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Research Foundation of Korea; Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Yeo Koon Kim, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Brain Ischemia; Carotid Artery Diseases; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Carotid Stenosis; Cerebral Infarction
• Other Study ID Numbers: B-1607-356-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No