Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-23 @ 2:22 PM
Study NCT ID:
NCT02923518
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2016-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2016-10-01', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences among two groups of senior athletes in detecting heart diseases by a screening program', 'timeFrame': 'One year', 'description': 'Examine if a simple screening program is efficient in detecting heart diseases'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Screening', 'Master Athletes', 'Cardiovascular Disease'], 'conditions': ['Heart Disease']}, 'descriptionModule': {'briefSummary': 'In 2010 there was published new European recommendations for assessment of adult and elderly men and women, who want to start with physical activity and/or participate in endurance contests. In this study we want to test if a group of people with positive score on a self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have more undetected heart diseases than a control group with no reported or detected risk factors.', 'detailedDescription': 'Forty senior athletes between 35 to approximately 80 yrs old with a positive score will be included in one group, and another forty seniors without positive score in a control group. Each of them will be tested with an cardiorespiratory exercise test (CPET) with ECG and examined with echocardiography together with an usual medical examination and blood tests (cholesterol and HbA1c-glucose). Some with symptoms of arrhythmias will be examined by 24-hours Holter-monitoring.\n\nThe main purpose of the study is to assess if men and women with a positive score on the questionnaire og NORRISK-screening (risk calculator for coronary heart disease) have more detectable heart diseases than the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Senior men and women \\< 35 yrs participating in long-enurance competitions. 40 persons in a group with positive score and one group without.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\> 35 yrs old Master athletes Positive score on symptom based questionnaire or high risk score No known heart disease Participated in long-term endurance competitions\n\nExclusion Criteria:\n\n\\< 35 yrs old Known heart disease'}, 'identificationModule': {'nctId': 'NCT02923518', 'acronym': 'MASTERSCREEN', 'briefTitle': 'Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)', 'organization': {'class': 'OTHER', 'fullName': 'LHL Helse'}, 'officialTitle': 'Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes) Who Participate in Long Distance Endurance Training and Competitions.', 'orgStudyIdInfo': {'id': '2016/21007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inclusion group', 'description': 'Inclusion group: Those with a positive score in a questionnaire including symptoms and family history and/or high risk-score in the NORRISK-score system.', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Control group', 'description': 'Those without a positive score on the two scores listed above.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Observational study without any intervention described under intervention type', 'armGroupLabels': ['Control group', 'Inclusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2093', 'city': 'Feiring', 'country': 'Norway', 'facility': 'LHL-clinics Feiring', 'geoPoint': {'lat': 60.48762, 'lon': 11.15682}}], 'overallOfficials': [{'name': 'Hege Lundring, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'General manager the LHL-clinics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LHL Helse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}