Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT03744533
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2018-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of modified Rankin Score of 0 to 2', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of modified Rankin Score of 0 to 1', 'timeFrame': '90 days'}, {'measure': 'proportion of early neurological deterioration', 'timeFrame': '48 hours', 'description': 'Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score'}, {'measure': 'The occurence of stroke or other vascular events', 'timeFrame': '90 days'}, {'measure': 'proportion of death of any cause', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head-down position', 'Large Artery Atherosclerosis'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '37147320', 'type': 'DERIVED', 'citation': 'Chen HS, Zhang NN, Cui Y, Li XQ, Zhou CS, Ma YT, Zhang H, Jiang CH, Li RH, Wan LS, Jiao Z, Xiao HB, Li Z, Yan TG, Wang DL, Nguyen TN. A randomized trial of Trendelenburg position for acute moderate ischemic stroke. Nat Commun. 2023 May 5;14(1):2592. doi: 10.1038/s41467-023-38313-y.'}]}, 'descriptionModule': {'briefSummary': 'Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient age over 18 years\n2. acute ischemic stroke within 24 h of onset\n3. neurological deficit: 6≤NIHSS≤16\n4. Large artery atherosclerosis etiology based on TOAST typing\n5. the supplied vessel is the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.\n6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1)\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Disturbance of consciousness\n2. Hemorrhagic stroke or mixed stroke\n3. Combining with severe organ dysfunction\n4. Past hemorrhagic stroke\n5. A history of stroke with severe sequelae\n6. Planned revascularization within 3 months\n7. Ischemic stroke due to surgical intervention\n8. participating in other clinical trials within 3 months\n9. Pregnant or lactating women\n10. any inappropriate patient assessed by the researcher'}, 'identificationModule': {'nctId': 'NCT03744533', 'acronym': 'HOPES2', 'briefTitle': 'Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial', 'orgStudyIdInfo': {'id': 'k （2018）38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'head-down position treatment', 'interventionNames': ['Other: head-down position treatment', 'Other: guideline-based treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'guideline-based treatment', 'interventionNames': ['Other: guideline-based treatment']}], 'interventions': [{'name': 'head-down position treatment', 'type': 'OTHER', 'description': 'the head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively.', 'armGroupLabels': ['head-down position treatment']}, {'name': 'guideline-based treatment', 'type': 'OTHER', 'description': 'guideline-based treatment', 'armGroupLabels': ['guideline-based treatment', 'head-down position treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'country': 'China', 'facility': 'General Hospital of ShenYang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Huisheng Chen, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Chairman', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}