Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02668627
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2016-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-days functional outcome', 'timeFrame': '90-days', 'description': '90-days modified Rankin Scale ≤ 2'}], 'secondaryOutcomes': [{'measure': 'Early neurologic improvement', 'timeFrame': '24 hours', 'description': 'An 8-point or more improvement on the NIH score when comparing the baseline score or a NIHSS score of 0-1, at 24 hours.'}, {'measure': 'Symptomatic hemorrhagic transformation', 'timeFrame': 'During initial admission', 'description': 'Occurrence of an increase in the National Institutes of Health Stroke Scale (NIHSS) score of 4 or more points in the setting of local or remote parenchymal hematoma.'}, {'measure': 'Successful recanalization', 'timeFrame': 'within 24 hours of symptom onset', 'description': 'Defined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Collateral status', 'Endovascular treatment'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '31554502', 'type': 'DERIVED', 'citation': 'Yu I, Bang OY, Chung JW, Kim YC, Choi EH, Seo WK, Kim GM, Menon BK, Demchuk AM, Goyal M, Hill MD. Admission Diffusion-Weighted Imaging Lesion Volume in Patients With Large Vessel Occlusion Stroke and Alberta Stroke Program Early CT Score of >/=6 Points: Serial Computed Tomography-Magnetic Resonance Imaging Collateral Measurements. Stroke. 2019 Nov;50(11):3115-3120. doi: 10.1161/STROKEAHA.119.026229. Epub 2019 Sep 26.'}]}, 'descriptionModule': {'briefSummary': "Based on the results of recent randomized controlled trials, current international guidelines recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour time window. In particular, treatment response to endovascular therapy may be greatly influenced by pretreatment collateral status. The aim of this study is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment in a wide range of patients with acute ischemic stroke ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute ischemic stroke, eligible for endovascular treatment within 12 hours of symptom onset', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke\n* Age 20 years and older\n* Disabling stroke defined as a baseline NIHSS \\> 5 at the time of arrival\n* Onset (last-seen-well) time to endovascular treatment time \\< 12 hours\n* Confirmed symptomatic intracranial occlusion, based on CT or MR angiography, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs)\n* Signed informed consent or appropriate signed deferral of consent where approved\n\nExclusion Criteria:\n\n* Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion.\n* Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic\n* Unable to undergo MRI (contraindicated or poor cooperation)\n* Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient\n* Pregnant females as determined by positive urine hCG test or lactating females'}, 'identificationModule': {'nctId': 'NCT02668627', 'briefTitle': 'MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)', 'orgStudyIdInfo': {'id': 'SMC 2013-12-088'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endovascular treatment', 'type': 'PROCEDURE', 'description': 'Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Won Chung, MD', 'role': 'CONTACT', 'email': 'neurocjw@gmail.com', 'phone': '82234101895'}, {'name': 'Oh Young Bang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kwang Ho Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chin-Sang Chung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gyeong-Moon Kim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jong-Won Chung, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jong-Won Chung, MD', 'role': 'CONTACT', 'email': 'neurocjw@gmail.com', 'phone': '82234103599'}, {'name': 'Yun Jeong Lim, RN', 'role': 'CONTACT', 'email': 'smcyunjeong@naver.com', 'phone': '82221489697'}], 'overallOfficials': [{'name': 'Oh Young Bang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Oh Young Bang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}