Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 6:52 PM
Study NCT ID:
NCT04977869
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with modified Rankin Scale (mRS) Score 0-2', 'timeFrame': '3 months', 'description': 'Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.'}], 'secondaryOutcomes': [{'measure': 'National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.', 'timeFrame': '24 hours, 7 days (or discharge)', 'description': 'National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 42, a low value represents a better outcome.'}, {'measure': 'Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.', 'timeFrame': '24 hours, 7 days (or discharge)', 'description': 'Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 100, a high value represents a better outcome.'}, {'measure': 'Proportion of patients with modified Rankin Scale (mRS) 0-1', 'timeFrame': '90±3 days', 'description': 'Proportion of patients with modified Rankin Scale (mRS) 0-1. Ranged from 0 to 6, a low value represents a better outcome.'}, {'measure': 'modified Rankin Scale (mRS) score distribution', 'timeFrame': '90±3 days', 'description': 'modified Rankin Scale (mRS) score distribution'}, {'measure': 'Recanalization rate within 7 days after EVT', 'timeFrame': '7 days', 'description': 'Recanalization rate within 7 days after EVT'}, {'measure': 'Early neurological deterioration at 7 days', 'timeFrame': '7 days', 'description': 'Early neurological deterioration at 7 days'}, {'measure': 'Frequency of Hemorrhagic transformation within 7 days', 'timeFrame': '7 days', 'description': 'Frequency of Hemorrhagic transformation within 7 days'}, {'measure': 'Frequency of symptomatic intracranial hemorrhage within 7 days', 'timeFrame': '7 days', 'description': 'Frequency of symptomatic intracranial hemorrhage within 7 days'}, {'measure': 'Death within 90 days', 'timeFrame': '90±3 days', 'description': 'Death within 90 days'}, {'measure': 'Frequency of adverse events within 90 days', 'timeFrame': '90±3 days', 'description': 'Frequency of adverse events within 90 days'}, {'measure': 'Adverse events associated with remote ischemic conditioning within 90 days', 'timeFrame': '90±3 days', 'description': 'Adverse events associated with remote ischemic conditioning within 90 days'}, {'measure': 'Frequency of serious adverse events within 90 days', 'timeFrame': '90±3 days', 'description': 'Frequency of serious adverse events within 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.', 'detailedDescription': 'In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age ≥ 18 years, male or female\n* 2\\) Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)\n* 3\\) Pre-EVT NIHSS ≥ 6\n* 4\\) Premorbid mRS ≤ 2\n* 5\\) Written informed consent obtained from the patient or legally responsible person\n\nExclusion Criteria:\n\n* 1\\) Contraindication of endovascular thrombectomy\n* 2\\) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome\n* 3\\) Head CT showing cerebral hernia and midline displacement\n* 4\\) Pregnancy or lactation\n* 5\\) Previous remote ischemic conditioning therapy or similar treatment\n* 6\\) Severe hepatic and renal dysfunction\n* 7\\) Life expectancy of less than 3 months or inability to complete the study for other reasons\n* 8\\) Unwilling to be followed up or poor compliance\n* 9\\) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission\n* 10\\) Other conditions that the researchers think make the patient unsuitable for the study'}, 'identificationModule': {'nctId': 'NCT04977869', 'briefTitle': 'Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SERIC-EVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RIC+Standard medical treatment', 'description': 'RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.', 'interventionNames': ['Procedure: Remote ischemic conditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham RIC+Standard medical treatment', 'description': 'Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.', 'interventionNames': ['Procedure: Sham remote ischemic conditioning']}], 'interventions': [{'name': 'Remote ischemic conditioning', 'type': 'PROCEDURE', 'description': 'Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.', 'armGroupLabels': ['RIC+Standard medical treatment']}, {'name': 'Sham remote ischemic conditioning', 'type': 'PROCEDURE', 'description': 'Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.', 'armGroupLabels': ['Sham RIC+Standard medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associated Dean of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}