Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-26 @ 11:57 PM
Study NCT ID:
NCT01654666
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jixunming@vip.163.com', 'phone': '8683198127', 'title': 'Xunming Ji, M.D.,Ph.D', 'organization': 'XuanWu Hospital, Capital Medical University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through 6 months post carotid artery stenting.', 'eventGroups': [{'id': 'EG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.', 'otherNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.', 'otherNumAtRisk': 56, 'otherNumAffected': 26, 'seriousNumAtRisk': 56, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.', 'otherNumAtRisk': 54, 'otherNumAffected': 23, 'seriousNumAtRisk': 54, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'At least one new lesion', 'notes': 'Number of participant with new DWI lesions on post-treatment MRI scans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyperperfusion Syndrome', 'notes': 'The hyperperfusion syndrome is characterized by headache, focal motor seizures and intracerebral hemorrhage, it can be evidenced by head Computed Tomography, Magnetic Resonance Imaging, Electroencephalogram.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Symptomatic Ischemic Stroke', 'notes': 'Symptomatic ischemic stroke is defined as an acute neurological event lasting over 24 hours with focal signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'notes': 'Transient ischemic attack (TIA) is a brief episode (\\<24 hours) of neurologic dysfunction resulting from focal temporary cerebral ischemia not associated with cerebral infarction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'title': 'Ischemic stroke within 6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'TIA within 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'No cerebrovascular event within 6 months', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'No Cardiovascular Events', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'No Deaths', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within six months after carotid artery stenting', 'description': 'Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population only included participants who fully completed the study.'}, {'type': 'PRIMARY', 'title': 'Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'title': 'With new lesions on post-treatment scans', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Without new lesions on post-treatment scans', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 48 hours after carotid artery stenting.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.'}, {'type': 'SECONDARY', 'title': 'Serum High-sensitive C-reactive Protein (Hs-CRP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '4.73'}, {'value': '1.22', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '4.67'}, {'value': '1.37', 'groupId': 'OG002', 'lowerLimit': '0.81', 'upperLimit': '3.77'}]}]}, {'title': 'On admission', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '3.51'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '2.56'}, {'value': '1.35', 'groupId': 'OG002', 'lowerLimit': '0.57', 'upperLimit': '3.69'}]}]}, {'title': '1 hour after CAS', 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '2.93'}, {'value': '1.46', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '3.60'}, {'value': '1.55', 'groupId': 'OG002', 'lowerLimit': '1.09', 'upperLimit': '4.18'}]}]}, {'title': '24 hours after CAS', 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '11.54'}, {'value': '7.90', 'groupId': 'OG001', 'lowerLimit': '4.63', 'upperLimit': '13.90'}, {'value': '6.90', 'groupId': 'OG002', 'lowerLimit': '3.75', 'upperLimit': '9.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 6 months after treatment.', 'description': 'The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Neuron Specific Enolase (NSE) Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.83', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '12.51', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '12.12', 'spread': '2.76', 'groupId': 'OG002'}]}]}, {'title': 'On admission', 'categories': [{'measurements': [{'value': '12.63', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '12.85', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '12.56', 'spread': '2.71', 'groupId': 'OG002'}]}]}, {'title': '1 hour after CAS', 'categories': [{'measurements': [{'value': '13.00', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '13.18', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '13.01', 'spread': '4.32', 'groupId': 'OG002'}]}]}, {'title': '24 hours after CAS', 'categories': [{'measurements': [{'value': '12.65', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '12.97', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '12.77', 'spread': '3.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.'}, {'type': 'SECONDARY', 'title': 'Serum S-100B Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'OG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '49.64', 'spread': '15.74', 'groupId': 'OG000'}, {'value': '50.14', 'spread': '17.04', 'groupId': 'OG001'}, {'value': '50.42', 'spread': '13.62', 'groupId': 'OG002'}]}]}, {'title': 'On admission', 'categories': [{'measurements': [{'value': '49.70', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '50.75', 'spread': '16.79', 'groupId': 'OG001'}, {'value': '51.24', 'spread': '13.30', 'groupId': 'OG002'}]}]}, {'title': '1 hour after CAS', 'categories': [{'measurements': [{'value': '50.99', 'spread': '20.21', 'groupId': 'OG000'}, {'value': '51.19', 'spread': '22.40', 'groupId': 'OG001'}, {'value': '51.79', 'spread': '19.42', 'groupId': 'OG002'}]}]}, {'title': '24 hours after CAS', 'categories': [{'measurements': [{'value': '51.40', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '52.94', 'spread': '24.34', 'groupId': 'OG001'}, {'value': '52.02', 'spread': '19.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'FG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'Primary Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Symptomatic and asymptomatic subjects with carotid artery stenosis which was more than 70% by angiography , duplex ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (NASCET criteria), who could undergo carotid artery stenting and all follow-ups, were recruited starting from August 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.\n\nRemote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'BG002', 'title': 'Sham RIPC Group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.\n\nSham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.\n\nCarotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.49', 'spread': '8.63', 'groupId': 'BG000'}, {'value': '66.47', 'spread': '8.54', 'groupId': 'BG001'}, {'value': '65.71', 'spread': '8.61', 'groupId': 'BG002'}, {'value': '66.56', 'spread': '8.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Han race', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-treatment scans', 'classes': [{'title': 'New DWI lesions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'No new DWI lesions', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical manifestation', 'classes': [{'title': 'Symptomatic', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}, {'title': 'Asymptomatic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Clinical manifestation of the target carotid artery stenosis.', 'unitOfMeasure': 'participants'}, {'title': 'Contralateral carotid condition', 'classes': [{'title': 'Severe stenosis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Occlusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Analysis Population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2012-07-23', 'resultsFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2012-07-28', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-13', 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.', 'timeFrame': 'Within six months after carotid artery stenting', 'description': 'Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.'}, {'measure': 'Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.', 'timeFrame': 'Within 48 hours after carotid artery stenting.'}], 'secondaryOutcomes': [{'measure': 'Serum High-sensitive C-reactive Protein (Hs-CRP).', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.'}, {'measure': 'Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.', 'timeFrame': 'From baseline to 6 months after treatment.', 'description': 'The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.'}, {'measure': 'Serum Neuron Specific Enolase (NSE) Levels.', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.'}, {'measure': 'Serum S-100B Levels.', 'timeFrame': 'Baseline, on admission, and 1 and 24 hours after carotid artery stenting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Remote ischemic preconditioning', 'Stroke secondary prevention', 'Carotid artery stenting', 'Carotid stenosis', 'Inflammation'], 'conditions': ['Carotid Artery Stenosis']}, 'referencesModule': {'references': [{'pmid': '36645250', 'type': 'DERIVED', 'citation': 'Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.'}, {'pmid': '28174194', 'type': 'DERIVED', 'citation': 'Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting.', 'detailedDescription': 'BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Our previous study found no significant protection to the patients who received once RIPC before Carotid Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery Stenting can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.\n\nDESIGNING: About 189 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1:1 ratio to RIPC group, sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least two weeks before carotid artery stenting. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least two weeks before carotid artery stenting. Patients in the control group receive conventional carotid artery stenting without RIPC or sham RIPC treatment. Cerebral injury is assessed by serum S-100B and Neuron specific enolase (NSE), systematic inflammation is assessed by serum high-sensitivity C-reactive protein (hs-CRP). Post-treatment infarctions, both symptomatic and asymptomatic, are detected by diffusion-weighted imaging (DWI) and clinical outcomes are determined by cerebrovascular events, cardiac events or death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);\n2. Tolerance to any of the study medications, including clopidogrel, aspirin and statins;\n3. Can cooperate with and complete brain MRI examination;\n4. Has a negative pregnancy test within 7 days before randomization and no childbearing potential;\n5. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;\n6. No hemorrhagic tendency;\n7. Stable vital sign, normal renal and hepatic functions;\n8. Informed consent.\n\nExclusion Criteria:\n\n1. Evolving stroke;\n2. Prior major ipsilateral stroke, if likely to confound study endpoints;\n3. Severe dementia;\n4. Hemorrhagic conversion of an ischemic stroke within the past 60 days;\n5. Chronic atrial fibrillation;\n6. Myocardial infarction within previous 30 days;\n7. Inability to understand and cooperate with study procedures or provide informed consent;\n8. Participating in other device or drug trial that has not completed the required protocol follow-up period;\n9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;\n10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);\n11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm);\n12. Blood pressure cannot be controlled lower than 200 mmHg by medications;\n13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).'}, 'identificationModule': {'nctId': 'NCT01654666', 'briefTitle': 'Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting', 'orgStudyIdInfo': {'id': 'RIPC2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment.\n\nDevice:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least two weeks before carotid artery stenting.\n\nProcedure: Carotid Artery Stenting', 'interventionNames': ['Procedure: Remote ischemic preconditioning', 'Procedure: Carotid Artery Stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Treatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting', 'interventionNames': ['Procedure: Carotid Artery Stenting']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham RIPC group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment.\n\nDevice:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in RIPC group do it twice a day for at least two weeks before carotid artery stenting.\n\nProcedure: Carotid Artery Stenting', 'interventionNames': ['Procedure: Sham remote ischemic preconditioning', 'Procedure: Carotid Artery Stenting']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['RIPC'], 'description': 'Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.', 'armGroupLabels': ['RIPC group']}, {'name': 'Sham remote ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['Sham RIPC'], 'description': 'Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.', 'armGroupLabels': ['Sham RIPC group']}, {'name': 'Carotid Artery Stenting', 'type': 'PROCEDURE', 'otherNames': ['CAS'], 'description': 'Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.', 'armGroupLabels': ['Control group', 'RIPC group', 'Sham RIPC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Baojun Hou', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xunming Ji M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ji Xunming', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'XuanWu Hospital', 'investigatorFullName': 'Ji Xunming', 'investigatorAffiliation': 'Capital Medical University'}}}}