Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT06965218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relation Between Aortic Sclerosis &Severity of Coronary Heart Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relation between Aortic valve sclerosis and severity of coronary heart disease', 'timeFrame': '6 months', 'description': 'significant relation between severity of aortic valve sclerosis assessed by trans thoracic echo doppler quantified by Chandra et al on a scale of 0 to 3.\n\n0 (no involvement).\n\n1. mild (minor involvement of one leaflet)\n2. moderate (minor involvement of two leaflets or extensive involvement of one leaflet.\n3. severe (extensive involvement of two leaflets or involvement of all three leaflets).\n\nAnd severity of coronary heart disease in patients already underwent or planned to perform coronary angiography quantified by syntax score considering score above 20 as severe coronary heart disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Sclerosis']}, 'descriptionModule': {'briefSummary': 'the goal of the study to identify the relation between aortic valve sclerosis and severity of coronary heart disease by performing transthoracic echo Doppler study for severity of aortic valve sclerosis in patient will undergo coronary angiography with calculation of syntax score as a tool for severity of coronary heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100a patients from both sex who are diagnosed to be aortic valve sclerosis and will undergo coronary angiography in Sohag university hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic sclerosis diagnosed by trans thoracic echo doppler\n\nExclusion Criteria:\n\n* patients who known to be Rumatic heart disease or congenital aortic valve disease.'}, 'identificationModule': {'nctId': 'NCT06965218', 'briefTitle': 'Relation Between Aortic Sclerosis &Severity of Coronary Heart Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Relation Between Aortic Valve Sclerosis and Severity of Coronary Heart Disease Assessed by Syntax Score in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-25-4___1MD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trans thoracic echo doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aortic valve sclerosis severity study be transthoracic echo doppler'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Ali shaker, MD', 'role': 'CONTACT', 'email': 'mohamed_ali_post@med.sohag.edu.eg', 'phone': '0021003474075'}], 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Ali shaker, MD', 'role': 'CONTACT', 'email': 'mohamed_ali_post@med.sohag.edu.eg', 'phone': '0021003474075'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'cardiologist', 'investigatorFullName': 'Mohamed Aly Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}