Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 1:56 AM
Study NCT ID:
NCT01838356
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000088323', 'term': 'Vascular Depression'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.', 'timeFrame': '12 months', 'description': 'Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Vascular depression', 'Intracranial atherosclerosis', 'Coronary artery disease', 'Coronary artery bypass graft', 'Cognitive impairment'], 'conditions': ['Depression', 'Intracranial Atherosclerosis', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '37684728', 'type': 'DERIVED', 'citation': 'Choi JJ, Kukla B, Walsh P, Oldham MA, Lee HB. Functional, cognitive, and cerebrovascular aspects of depression before coronary artery bypass graft surgery: Testing the vascular depression hypothesis. Int J Geriatr Psychiatry. 2023 Sep;38(9):e6000. doi: 10.1002/gps.6000.'}, {'pmid': '26423721', 'type': 'DERIVED', 'citation': 'Oldham MA, Hawkins KA, Yuh DD, Dewar ML, Darr UM, Lysyy T, Lee HB. Cognitive and functional status predictors of delirium and delirium severity after coronary artery bypass graft surgery: an interim analysis of the Neuropsychiatric Outcomes After Heart Surgery study. Int Psychogeriatr. 2015 Dec;27(12):1929-38. doi: 10.1017/S1041610215001477. Epub 2015 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery.\n\nThe main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population for this study will be drawn from cardiac surgery patients at a university-based hospital who will undergo coronary artery bypass graft (CABG) surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 40 years or older\n* Will be having CABG surgery at the Yale New Haven Hospital\n* Be able to provide informed consent\n* Have a household telephone\n* A fluent English speaker, and possessing no communication barrier\n* Be able to come to the study site or to have the study team come to his/her home.\n* Has a family member or partner/ friend who could provide collateral information\n\nExclusion Criteria:\n\n* Has had previous CABG surgery\n* History of dementia diagnosis or cognitive impairment (CDR \\>/= 1)\n* Auditory or visual impairment that would interfere with study procedures\n* Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items)\n* History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report.\n* Presence of non-cardiovascular conditions likely to be fatal within 1 year'}, 'identificationModule': {'nctId': 'NCT01838356', 'acronym': 'NOAHS', 'briefTitle': 'Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Intracranial Atherosclerosis and Predictors of Post-CABG Depression', 'orgStudyIdInfo': {'id': '1202009664'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}