Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-02-24 @ 4:27 AM
Study NCT ID:
NCT03283306
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 667}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of recurrent stroke, vascular death and myocardial infarction', 'timeFrame': '12 months', 'description': '(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)'}], 'secondaryOutcomes': [{'measure': 'Ipsilateral stroke', 'timeFrame': '12 months', 'description': 'Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)'}, {'measure': 'All-cause mortality', 'timeFrame': '12 months', 'description': 'All of the deaths, regardless of the cause'}, {'measure': 'Carotid intervention', 'timeFrame': '12 months', 'description': 'Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasonography', 'Carotid Stenosis', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients older than 19 years presenting acute ischemic stroke.\n2. Compatible neurologic symptom within 14 days\n3. 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\n4. Etiology of acute ischemic stroke: except cardioembolic stroke (Atrial fibrillation) and other determined etiology\n5. Ipsilateral extracranial carotid artery stenosis on MRA (CE-MRA), CTA or Doppler ultrasound\n\nExclusion Criteria:\n\n1. History of ipsilateral carotid stent or endarterectomy\n2. Carotid intervention during hospital stay\n3. 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)\n4. Expected life span less than 12 months'}, 'identificationModule': {'nctId': 'NCT03283306', 'briefTitle': 'Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prognostic Value of Carotid Contrast-Enhanced Ultrasound in Acute Ischemic Stroke Patients for Cerebrovascular and Cardiovascular Event', 'orgStudyIdInfo': {'id': 'B-1607-356-304'}}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yumi Kim', 'role': 'CONTACT', 'email': '98716@snubh.org', 'phone': '+82-31-787-8872'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Yeo Koon Kim, MD', 'role': 'CONTACT', 'email': 'yeokoon@snubh.org', 'phone': '82-10-3460-0660'}, {'name': 'Eun Jung Kim', 'role': 'CONTACT', 'email': 'jfhg92@naver.com', 'phone': '82-10-2450-3988'}], 'overallOfficials': [{'name': 'Yeo Koon Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yeo Koon Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}