Ignite Creation Date:
2025-12-26 @ 11:50 AM
Ignite Modification Date:
2025-12-26 @ 11:50 AM
Study NCT ID:
NCT01442116
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2011-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of LVOT velocity before and after exercise by echocardiography', 'timeFrame': '1 day (before and after exercise stress)'}, {'measure': 'measurement of TDI S wave before and after exercise by echocardiography', 'timeFrame': '1 day (before and after exercise)'}], 'secondaryOutcomes': [{'measure': 'myocardial regional functions measured by tissue Doppler imagination', 'timeFrame': '1 day'}]}, 'conditionsModule': {'conditions': ['Hypertension', 'Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Essential hypertension\n\nExclusion Criteria:\n\n* History of Myocardial Infarction\n* Diabetes Mellitus\n* Renal Failure\n* Orthopedic problems'}, 'identificationModule': {'nctId': 'NCT01442116', 'briefTitle': 'Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension', 'orgStudyIdInfo': {'id': 'HT60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertensives', 'interventionNames': ['Procedure: stress echocardiography']}], 'interventions': [{'name': 'stress echocardiography', 'type': 'PROCEDURE', 'description': 'safety and efficacy of stress echocardiography', 'armGroupLabels': ['Hypertensives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31100', 'city': 'Antioch', 'state': 'Antioch', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Kemal University School of Medicine, Department of Cardiology', 'geoPoint': {'lat': 36.20655, 'lon': 36.15722}}], 'overallOfficials': [{'name': 'Fatih Yalcin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mustafa Kemal University: Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Nagehan Kucukler', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}