Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT07242768
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New ischemic stroke events', 'timeFrame': 'Within 3 years after randomization'}], 'secondaryOutcomes': [{'measure': 'New ischemic stroke and transient ischemic attack events in the responsible vessel supply area', 'timeFrame': 'Within 3 years after randomization'}, {'measure': 'New ischemic stroke and transient ischemic attack events', 'timeFrame': 'Within 3 years after randomization'}, {'measure': 'Hemorrhagic stroke events', 'timeFrame': 'Within 3 years after randomization'}, {'measure': 'Myocardial infarction events', 'timeFrame': 'Within 3 years after randomization'}, {'measure': 'Proportion of patients achieving modified Rankin Scale score (mRS) 0-1', 'timeFrame': 'At 3 years after randomization', 'description': 'The modified Rankin scale (range, 0 \\[no symptoms\\] to 6 \\[death\\], with higher scores indicating greater disability)'}, {'measure': 'The score of mini-Montreal Cognitive Assessment', 'timeFrame': 'At 3 years after randomization', 'description': 'The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)'}, {'measure': 'Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)', 'timeFrame': 'At 3 years after randomization', 'description': 'The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n'}, {'measure': 'Rate of Falls', 'timeFrame': 'Within 3 years after randomization'}, {'measure': 'All-cause death', 'timeFrame': 'Within 3 years after randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Transient Ischemic Attack', 'Symptomatic intracranial arterial stenosis'], 'conditions': ['Ischemic Stroke', 'Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': 'This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.', 'detailedDescription': "This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.\n\nAfter completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.\n\nApproximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include the subjects who enrolled in the RESIST trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who enrolled in the RESIST trial and completed the 12-month follow-up.\n2. Written informed consent to participate in this 3-year observational extension.\n\nExclusion Criteria:\n\nParticipants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.'}, 'identificationModule': {'nctId': 'NCT07242768', 'acronym': 'RESIST-FE', 'briefTitle': 'Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial', 'orgStudyIdInfo': {'id': 'SPORTS1102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regular Physical Exercise Group', 'description': 'Participants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up.', 'interventionNames': ['Other: Non-Interventional Study']}, {'label': 'Control Group', 'description': 'Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.', 'armGroupLabels': ['Control Group', 'Regular Physical Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanjie Wu', 'role': 'CONTACT', 'email': 'wuchuanjie@ccmu.edu.cn', 'phone': '01083199439'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xunming Ji', 'role': 'CONTACT', 'email': 'jixm@ccmu.edu.cn', 'phone': '01083198962'}, {'name': 'Chuanjie Wu', 'role': 'CONTACT', 'email': 'wuchuanjie@ccmu.edu.cn', 'phone': '01083199439'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study is proceeding.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology, Xuanwu Hospital, Capital Medical University', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}