Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00795405
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Effects of Sporting Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-04', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of definite myocardial ischemia confirmed by Holter monitoring', 'timeFrame': '2 months'}, {'measure': 'Blood pressure measured by ambulatory blood pressure monitoring', 'timeFrame': '2 months'}, {'measure': 'Heart rate variability', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Episode of angina', 'timeFrame': '3 months'}, {'measure': 'Episode of neurological events', 'timeFrame': '3 months'}, {'measure': 'Episode of arrhythmia', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sporting events', 'stress', 'myocardial ischemia', 'ST-segment depression', 'blood pressure'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'Major sporting events may have adverse cardiovascular effects in subjects with coronary heart disease. We also hypothesized that the adverse cardiovascular effects of sporting events are a result of psychobiological processes including stress-induced hemodynamic changes, autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic responses, all of which may in turn promote myocardial ischemia.', 'detailedDescription': 'Observational studies suggest that exposure to sporting events may worsen symptoms of angina and trigger acute myocardial infarction. The mechanisms for this association are unknown. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of sporting events.\n\nIn a randomized crossover controlled study, 38 patients with prior myocardial infarction will be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography, and blood pressure change will be analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be measured.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous myocardial infarction (\\>6 months previously)treated by coronary revascularization\n* On standard secondary preventative therapy\n\nExclusion Criteria:\n\n* Angina pectoris (Canadian Cardiovascular Society grade ≥2)\n* History of arrhythmia\n* Uncontrolled hypertension\n* Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)\n* Occupational exposure to sporting events\n* Diabetes\n* Hepatic or renal failure'}, 'identificationModule': {'nctId': 'NCT00795405', 'briefTitle': 'Cardiovascular Effects of Sporting Events', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'sporting events'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1', 'description': 'No exposure to sporting events', 'interventionNames': ['Behavioral: No exposure to sporting events']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Exposure to sporting events', 'interventionNames': ['Behavioral: Exposure to sporting events']}], 'interventions': [{'name': 'Exposure to sporting events', 'type': 'BEHAVIORAL', 'description': 'Exposure to sporting events', 'armGroupLabels': ['2']}, {'name': 'No exposure to sporting events', 'type': 'BEHAVIORAL', 'description': 'No exposure to sporting events', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shengshou Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Institue and Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Shengshou Hu / President', 'oldOrganization': 'Cardiovascular Institute & Fuwai Hospital'}}}}