Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-04 @ 9:47 PM
Study NCT ID:
NCT03481205
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the feasibility of delivering RLIC by air medical crews in patients with AIS. This will be assessed by recording the number of cycles completed during transport.', 'timeFrame': 'The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital', 'description': 'Feasibility will be assessed based on the number of cycles performed during transportation by air as follows:\n\nFor flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC.\n\nFor flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC.\n\nFor flight duration of \\< 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.'}], 'secondaryOutcomes': [{'measure': 'Assess adverse events related to performing RLIC in patients with large vessel occlusion.', 'timeFrame': 'AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.', 'description': 'We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['remote limb ischemic conditioning', 'large vessel occlusion', 'helicopter transport'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.', 'detailedDescription': 'In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.\n\nThe RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.\n\nSubjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.\n\nThe study will be conducted at one site ( University of Iowa Hospitals and Clinics)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and ≤ 80 years\n2. Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).\n3. Patient screened for rtPA, and rtPA administered if eligible\n4. Subject or legally authorized representative able to provide consent at the time of the assessment\n5. NIHSS 6-20\n\nExclusion Criteria:\n\n1. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital\n2. History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment\n3. History of diabetes mellitus\n4. Enrollment in another clinical trial\n5. Patient incarcerated\n6. Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.\n7. Agitation deemed unsafe for ischemic preconditioning testing.\n8. Arteriovenous fistula in upper limb'}, 'identificationModule': {'nctId': 'NCT03481205', 'acronym': 'ICARUS', 'briefTitle': 'Ischemic Conditioning During Air tRansport Save penUmbral Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Ischemic Conditioning During Air tRansport Save penUmbral Tissue', 'orgStudyIdInfo': {'id': '201712791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ischemic Conditioning', 'description': 'Doctormate device used en route to the comprehensive stroke center', 'interventionNames': ['Device: Ischemic conditioning device']}], 'interventions': [{'name': 'Ischemic conditioning device', 'type': 'DEVICE', 'otherNames': ['Standard medical care'], 'description': 'RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.', 'armGroupLabels': ['Ischemic Conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Enrique Leira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Amir Shaban, MD', 'role': 'CONTACT', 'email': 'amir-shaban@uiowa.edu', 'phone': '3193568755'}], 'overallOfficials': [{'name': 'Enrique Leira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enrique Leira', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Enrique Leira', 'investigatorAffiliation': 'University of Iowa'}}}}