Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT03454594
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2018-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2018-02-25', 'studyFirstSubmitQcDate': '2018-03-03', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of blood pressure', 'timeFrame': '8 weeks', 'description': 'measuring blood pressure before and after each low level laser radiation'}], 'secondaryOutcomes': [{'measure': 'changes in blood viscosity', 'timeFrame': '8 weeks', 'description': 'measuring changes in blood viscosity before and after low level laser radiation session'}, {'measure': 'change in IL-17 level', 'timeFrame': '45 days', 'description': 'measuring changes in IL-17 level before and after low level laser radiation session'}, {'measure': 'change in functional capacity', 'timeFrame': '70 days', 'description': 'measuring of 6 minute walking test before and after low level laser irradiation as an indicator of functional capacity improving'}, {'measure': 'change in CD 8 (cluster of differentiation 8) level', 'timeFrame': '45 days', 'description': 'measuring changes in CD 8 (cluster of differentiation 8) level before and after low level laser radiation session'}, {'measure': 'change in TC (total cholesterol) level', 'timeFrame': '60 days', 'description': 'measuring changes in TC (total cholesterol) level before and after low level laser radiation session'}, {'measure': 'change in LDL (low density lipoprotien) level', 'timeFrame': '60 days', 'description': 'measuring changes in LDL (low density lipoprotien) level before and after low level laser radiation session'}, {'measure': 'change in TG (triglyceride) level', 'timeFrame': '60 days', 'description': 'measuring changes in TG (triglyceride) level before and after low level laser radiation session'}, {'measure': 'change in HDL (high density lipoprotien) level', 'timeFrame': '60 days', 'description': 'measuring changes in HDL (high density lipoprotien) level before and after low level laser radiation session'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'high blood viscosity', 'hypercholesterolemia'], 'conditions': ['Cardiovascular Risk Factor', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)', 'detailedDescription': 'The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. Low Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage I hypertensive patients\n* patients from 30 to 34.9 kg/m2 body mass index\n* medically stable patients\n* all participants have sufficient cognition enough to understand the requirements of the study\n\nExclusion Criteria:\n\n* history of malignant disease\n* smoking\n* history of progressive fatal disease\n* history of drug or alcohol abuse\n* blood donation within at least 30 days\n* pregnant, trying to be pregnant or breast feeding\n* cognitive impairment that will make it difficult to partake in the study'}, 'identificationModule': {'nctId': 'NCT03454594', 'briefTitle': 'Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low level laser hemotherapy', 'description': 'Watch laser acupuncture and nasal irradiation', 'interventionNames': ['Device: low level laser hemotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'all the participants in this group did not receive low level laser irradiation during the study period'}], 'interventions': [{'name': 'low level laser hemotherapy', 'type': 'DEVICE', 'otherNames': ['Watch laser'], 'description': 'semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity', 'armGroupLabels': ['low level laser hemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'Cairo', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Cairo Giza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'data will be available after 6 months of study completion and ending 36 months', 'ipdSharing': 'YES', 'description': 'De-identified participated data for underlie results reported in this trial', 'accessCriteria': 'proposals should directed to Dr.EbtesamNagy@cu.edu.eg. To gain access, data requestors will need to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer assistance at Cairo University', 'investigatorFullName': 'Ebtesam Nabil', 'investigatorAffiliation': 'Cairo University'}}}}