NCT03283306

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

September 11, 2017

Last Update Submit

September 12, 2017

Conditions

UltrasonographyCarotid StenosisIschemic Stroke

Outcome Measures

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)

    12 months

Secondary Outcomes (3)

  • Ipsilateral stroke

    12 months

  • All-cause mortality

    12 months

  • Carotid intervention

    12 months

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.

You may qualify if:

  • Patients older than 19 years presenting acute ischemic stroke.
  • Compatible neurologic symptom within 14 days
  • 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
  • Etiology of acute ischemic stroke: except cardioembolic stroke (Atrial fibrillation) and other determined etiology
  • Ipsilateral extracranial carotid artery stenosis on MRA (CE-MRA), CTA or Doppler ultrasound

You may not qualify if:

  • History of ipsilateral carotid stent or endarterectomy
  • Carotid intervention during hospital stay
  • 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)
  • Expected life span less than 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Carotid StenosisIschemic Stroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Yeo Koon Kim, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeo Koon Kim, MD

CONTACT

82-10-3460-0660yeokoon@snubh.org

Eun Jung Kim

CONTACT

82-10-2450-3988jfhg92@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 14, 2017

Study Start

August 9, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

KR(1)