Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 9:58 AM
Study NCT ID:
NCT01815567
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DETECT and Retinal Outcomes in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy)', 'timeFrame': '12 months', 'description': 'We aim to determine the correlation (if any) between the severity of blood pressure and DETECT neurocognitive outcomes as well as the correlation (if any) between known Hypertensive retinal disease and DETECT neurocognitive outcomes. Appropriate statistical analysis will be performed to compare clinical retinal findings, BP values, and DETECT neurocognitive test outcomes.\n\nSubject level data will only be collected on the day of Emergency Department presentation. Subjects will not be followed after their initial enrollment. The study duration is projected for 12 months'}], 'secondaryOutcomes': [{'measure': 'Variance of DETECT scores (Z-score) attributed to reading level', 'timeFrame': 'One year study periord (12 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Retinal Disorder', 'Cognitive impairment'], 'conditions': ['Hypertension', 'Retinal Disorder', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the impact of blood pressure on cognitive performance.', 'detailedDescription': 'Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency department patients that meet the inclusion/exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients triaged to the Grady Memorial Hospital Emergency Department or Marcus Trauma Unit\n2. Age \\>18 and \\<65\n3. Documented history of hypertension plus one or more of the following:\n\n * current antihypertensive use with controlled blood pressure\n * elevated Emergency Department systolic blood pressure or diastolic blood pressure\n * OR -\n4. Acutely elevated Emergency Department systolic blood pressure or diastolic blood pressure on 2 separate Emergency Department measurements in the absence of a history of hypertension\n\n * OR -\n5. Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Pre-visit cognitive impairment\n3. Physical or psychological impairments that would prohibit comprehension and completion of DETECT testing\n4. Inability to obtain adequate fundoscopic photos\n5. Acute intoxication, altered mental status, or head injury within the last 6 months\n6. Opiate or benzodiazepine administration by treating providers\n7. Clinical condition not allowing testing.'}, 'identificationModule': {'nctId': 'NCT01815567', 'briefTitle': 'DETECT and Retinal Outcomes in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events', 'orgStudyIdInfo': {'id': 'IRB00060043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'controlled hypertension', 'description': 'hypertension with medication controlled'}, {'label': 'uncontrolled hypertension', 'description': 'non-controlled hypertension'}, {'label': 'hypertensive urgency', 'description': 'hypertensive urgency no previous history or antihypertensives'}, {'label': 'asymptomatic normotensive', 'description': 'asymptomatic normotensive control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Tamara Espinoza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Tamara Espinoza, MD', 'investigatorAffiliation': 'Emory University'}}}}