Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT00266435
Status:
COMPLETED
Last Update Posted:
2008-03-26
First Post:
2005-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-25', 'studyFirstSubmitDate': '2005-12-15', 'studyFirstSubmitQcDate': '2005-12-15', 'lastUpdatePostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Asymptomatic subjects', 'Moderate to high risk for cardiovascular event'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the sensitivity and specificity of a new system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a conservative treadmill test in asymptomatic subjects, classified by Framingham score as moderate to high risk. Subjects will perform a routine exercise test with the addition of another set of electrodes to record high resolution ECG. All subjects will perform a stress echocardiography. The result of the routine ECG analysis will be compared to the new system and to the echocardiography results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary prevention program', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient referred to annual screening check\n* Classified as being at intermediate or high risk for the development of cardiovascular disease by the Framingham score.\n* Signed an Informed Consent Form\n\nExclusion Criteria:\n\n* A subject who cannot or should not perform an exercise test.'}, 'identificationModule': {'nctId': 'NCT00266435', 'briefTitle': 'The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing', 'orgStudyIdInfo': {'id': 'SHEBA-05-3693-ES-CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Ehud Schwammenthal, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}