Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT00975559
Status:
COMPLETED
Last Update Posted:
2012-04-26
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Catecholomines'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Endothelial Dysfunction', 'Apical Ballooning Syndrome', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Normal volunteers\n2. Apical Ballooning syndrome as proven during coronary angiogram\n3. Coronary Endothelial Dysfunction as proven during coronary angiogram\n4. Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be identified in one of the four groups outlined in "study population description."\n\nExclusion Criteria:\n\n* Other co-morbidities that would make the testing not possible.\n* Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.'}, 'identificationModule': {'nctId': 'NCT00975559', 'briefTitle': 'The Relationship Between the Response to Mental Stress and Vascular Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Relationship Between the Response to Mental Stress and Vascular Endothelial Function', 'orgStudyIdInfo': {'id': '1881-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal volunteers', 'description': 'Normal study volunteers with no prior history of coronary artery disease'}, {'label': 'Apical Ballooning Syndrome', 'description': 'Women who have had a documented Apical Ballooning event as shown by coronary angiogram'}, {'label': 'Coronary Endothelial Dysfunction', 'description': 'Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge'}, {'label': 'Myocardial Infarction', 'description': 'Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Amir Lerman', 'investigatorAffiliation': 'Mayo Clinic'}}}}