Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-24 @ 8:09 AM
Study NCT ID:
NCT01953068
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2013-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2013-09-25', 'studyFirstSubmitQcDate': '2013-09-25', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive Reaction Time Test response speed', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Executive Reaction Time Test: error% of answers', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['POCD', 'Executive Reaction Time Test', 'Aortic valve surgery', 'Cognitive functions', 'Transcatheter Aortic Valve Implantation'], 'conditions': ['Neurobehavioral Manifestations']}, 'referencesModule': {'references': [{'pmid': '27245618', 'type': 'DERIVED', 'citation': 'Liimatainen J, Perakyla J, Jarvela K, Sisto T, Yli-Hankala A, Hartikainen KM. Improved cognitive flexibility after aortic valve replacement surgery. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):630-6. doi: 10.1093/icvts/ivw170. Epub 2016 May 30.'}]}, 'descriptionModule': {'briefSummary': 'Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. Conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time.\n\nThe phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2)\n\nExclusion Criteria:\n\n* Previous neurological or psychiatric disorder.\n* Significant visual problem\n* Problems with upper arm/hand use'}, 'identificationModule': {'nctId': 'NCT01953068', 'briefTitle': 'Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures', 'orgStudyIdInfo': {'id': 'R13043'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital Heart Center', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Jonne Liimatainen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Kaisa Hartikainen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Behavioral Neurology Research Unit, Pirkanmaa Hospital District'}, {'name': 'Arvi Yli-Hankala, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Kati Järvelä, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital Heart Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kati järvelä, MD, PhD', 'investigatorFullName': 'Kati Järvelä', 'investigatorAffiliation': 'Tampere University Hospital'}}}}