Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT05598658
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral autoregulation parameter', 'timeFrame': '1-10 days', 'description': 'Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote Ischemic Conditioning', 'Intravenous Thrombolysis', 'Cerebral Hemodynamics', 'Cerebral Autoregulation', 'Cerebral Blood Flow Velocity'], 'conditions': ['Remote Ischemic Conditioning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis', 'detailedDescription': 'In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 and \\< 80 years, both sexes;\n2. a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;\n3. pre-onset modified Rankin Scale (mRS) score ≤1;\n4. baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;\n5. Glasgow Coma Scale score ≥8.\n\nExclusion Criteria:\n\n1. having received bridging therapy (IVT plus mechanical thrombectomy);\n2. previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;\n3. contraindications to RIC treatment or previous RIC treatment or similar treatment;\n4. pregnancy or breastfeeding;\n5. life expectancy of ≤3 months or inability to complete the study for other reasons;\n6. unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;\n7. had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.'}, 'identificationModule': {'nctId': 'NCT05598658', 'briefTitle': 'Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)', 'orgStudyIdInfo': {'id': 'RICCH-IVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RIC group', 'description': 'Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.', 'interventionNames': ['Procedure: Remote ischemic conditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham-RIC group', 'description': 'Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.', '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 inflations of a blood pressure cuff to 200 mm Hg.', 'armGroupLabels': ['RIC group']}, {'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 inflations of a blood pressure cuff to 60 mm Hg.', 'armGroupLabels': ['Sham-RIC group']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}