Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00634335
Status:
UNKNOWN
Last Update Posted:
2008-12-30
First Post:
2008-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Echocardiographic Characteristics of High Endurance Israeli Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-29', 'studyFirstSubmitDate': '2008-03-04', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Athlete's Heart"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.', 'detailedDescription': "Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race.\n\nAlthough many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be.\n\nSudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes.\n\nIn Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'professional bicyclists in Israel', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least.\n* Participated in at least one contest recognized by the bicyclists organization of Israel.\n* Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average\n\nExclusion Criteria:\n\n* Do not suffer any known cardiac disease\n* Had declared that they are not using drugs which are forbidden by the Olympic committee'}, 'identificationModule': {'nctId': 'NCT00634335', 'briefTitle': 'Echocardiographic Characteristics of High Endurance Israeli Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Echocardiographic Characteristics of High Endurance Israeli Athletes', 'orgStudyIdInfo': {'id': 'sor465808ctil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sk', 'description': 'professional Israeli bicyclists'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'KOBAL SERGIO, MD', 'role': 'CONTACT', 'email': 'kobal@bgu.ac.il', 'phone': '972-8-6400133'}, {'name': 'SERGIO KOBAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Sergio Kobal, MD', 'role': 'CONTACT', 'email': 'kobal@bgu.ac.il', 'phone': '972-8-6400133'}], 'overallOfficials': [{'name': 'Sergio Kobal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka medical center, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Sergio kobal', 'oldOrganization': 'Soroka medical center'}}}}