Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-13 @ 11:33 AM
Study NCT ID:
NCT00469794
Status:
UNKNOWN
Last Update Posted:
2007-05-07
First Post:
2007-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Significance of Arrhythmias in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-05-04', 'studyFirstSubmitDate': '2007-05-04', 'studyFirstSubmitQcDate': '2007-05-04', 'lastUpdatePostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arrhythmias', 'Athletes', 'exercise'], 'conditions': ['Sudden Death']}, 'descriptionModule': {'briefSummary': 'Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.', 'detailedDescription': 'Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.\n\nVentricular premature beats (VPB\'s) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the "athlete\'s heart syndrome" and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.\n\nTo date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Competitive athletes less than 35 YO\n* Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test\n* Competitive athletes with ventricular arrhythmia during exercise\n\nExclusion Criteria:\n\n* Athletes who don't meet the exclusion criteria."}, 'identificationModule': {'nctId': 'NCT00469794', 'acronym': 'Athlete', 'briefTitle': 'The Significance of Arrhythmias in Athletes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes', 'orgStudyIdInfo': {'id': '50/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stress test', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Therese Fuchs, MD', 'role': 'CONTACT', 'email': 'therese@fuchs.org', 'phone': '972-8-977-9730'}, {'name': 'Rutie Plitz-Burstein, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wingate Institute', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Therese Fuchs, MD', 'role': 'CONTACT', 'email': 'therese@fuchs.org', 'phone': '972-8-977-9730'}, {'name': 'Zvi Vered, MD', 'role': 'CONTACT', 'email': 'zvered@asaf.health.gov.il', 'phone': '972-8-977-9735'}], 'overallOfficials': [{'name': 'Therese Fuchs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assaf-Harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institute of Physical Education and Sports Sciences', 'class': 'OTHER'}]}}}