Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-08 @ 3:59 AM
Study NCT ID:
NCT02966418
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2016-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoxic Preconditioning on Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2016-11-06', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'Before, during and 5 min after the intervention.'}, {'measure': 'Heart rate', 'timeFrame': 'Before, during and 5 min after the intervention.'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Before, during and 5 min after the intervention.'}, {'measure': 'Arterial blood oxygen saturation', 'timeFrame': 'Before, during and 5 min after the intervention.'}, {'measure': 'Hemoglobin content', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Hypoxia inducible factor-1α', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Erythropoietin', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Vascular endothelial growth factor', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Neuron-specific enolase', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'S100β protein', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Brain-derived neurotrophic factor', 'timeFrame': 'On admission, and at the 1st day after surgery.'}], 'secondaryOutcomes': [{'measure': 'Serum aspartate transaminase', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Serum alanine aminotransferase', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Serum creatinine', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'Blood urea nitrogen', 'timeFrame': 'On admission, and at the 1st day after surgery.'}, {'measure': 'The incidence of adverse events', 'timeFrame': 'During the intervention.'}, {'measure': 'Average length of hospital stay', 'timeFrame': 'Through study completion, an average of 3 months.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Through study completion, an average of 3 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypoxic preconditioning', 'Carotid artery stenosis', 'Ischemic cerebrovascular disease'], 'conditions': ['Hypoxic Preconditioning', 'Carotid Artery Stenosis', 'Ischemic Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed written consent from the patient.\n2. Han nationality, age \\>18 years.\n3. Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy.\n4. Long-term residence at an altitude of \\<100 m (the altitude of Tianjin is 2-5 m).\n5. Not having been to an altitude ≥1500 m in two years.\n\nExclusion Criteria:\n\n1. Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment.\n2. Systemic blood disease before intervention.\n3. Regular physical activity exercise: frequency \\>1 time/week, duration \\>20 min.\n4. History of brain disease or history of stroke or transient ischemic attack within the previous six months.\n5. History of heart, liver, kidney or lung disease.\n6. History of hypertension and poor blood pressure control, with blood pressure \\>160/90 mmHg.\n7. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02966418', 'briefTitle': 'Hypoxic Preconditioning on Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis', 'orgStudyIdInfo': {'id': 'JH2016-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mild hypoxia preconditioning', 'description': 'Patients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery.', 'interventionNames': ['Procedure: Mild Hypoxia Preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham preconditioning', 'description': 'Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.', 'interventionNames': ['Procedure: Sham preconditioning']}], 'interventions': [{'name': 'Mild Hypoxia Preconditioning', 'type': 'PROCEDURE', 'description': 'Patients will be treated with mild hypoxia ( Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%)×7 days，twice a day in the morning and in the afternoon before surgery.', 'armGroupLabels': ['Mild hypoxia preconditioning']}, {'name': 'Sham preconditioning', 'type': 'PROCEDURE', 'description': 'Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.', 'armGroupLabels': ['Sham preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300350', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin HuanHu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Hua Yan, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Huanhu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hua Yan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hua Yan', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}