Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-29 @ 8:37 PM
Study NCT ID:
NCT00248859
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2005-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Cardiac Risk Factor Modification in Latinos With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Depressive symptoms', 'Latino American'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity.", 'detailedDescription': 'Specific aims: Among 213 Latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are:\n\n1. To determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. Physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework.\n2. To determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity.\n\nLong-term objectives: The long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of Latino adults with coronary artery disease.\n\nOutcome: The outcome is being in the action or maintenance stage of physical activity two years after angioplasty The stage of physical activity participation will be based on the Stages of Change model. This model describes behavior change as a continuum from pre-contemplation to contemplation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiovascular DiSease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients must identify their ethnicity as Latino or Hispanic\n* Patients must be able to complete a questionnaire in either English or Spanish.\n* Patients must have angiographic evidence of coronary artery disease requiring angioplasty\n* Patients must also be clinically stable for an interview\n* Patient must be able to provide informed consent.\n\nExclusion criteria\n\n* Patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired.\n* Patients who are unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT00248859', 'briefTitle': 'Determinants of Cardiac Risk Factor Modification in Latinos With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Determinants of Cardiac Risk Factors Modification', 'orgStudyIdInfo': {'id': 'HL076567-01'}, 'secondaryIdInfos': [{'id': '5K01HL076567', 'link': 'https://reporter.nih.gov/quickSearch/5K01HL076567', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Joan and Sanford I. Weill Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carla Boutin-Foster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Carla Boutin-Foster, MD', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}