DETECT and Retinal Outcomes in Hypertension
This study is currently recruiting participants.
Verified December 2016 by Tamara Espinoza, MD, Emory University
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University
First received: September 20, 2012
Last updated: December 21, 2016
Last verified: December 2016
The purpose of this study is to study the impact of blood pressure on cognitive performance.
||Observational Model: Case Control
Time Perspective: Prospective
||The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events
Primary Outcome Measures:
- DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy) [ Time Frame: 12 months ]
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.
Subject 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
Secondary Outcome Measures:
- Variance of DETECT scores (Z-score) attributed to reading level [ Time Frame: One year study periord (12 months) ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2017 (Final data collection date for primary outcome measure)
hypertension with medication controlled
hypertensive urgency no previous history or antihypertensives
asymptomatic normotensive control group
Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Emergency department patients that meet the inclusion/exclusion criteria.
- Patients triaged to the Grady Memorial Hospital Emergency Department or Marcus Trauma Unit
- Age >18 and <65
Documented history of hypertension plus one or more of the following:
- current antihypertensive use with controlled blood pressure
- elevated Emergency Department systolic blood pressure or diastolic blood pressure
- OR -
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
- Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.
- Non-English speaking
- Pre-visit cognitive impairment
- Physical or psychological impairments that would prohibit comprehension and completion of DETECT testing
- Inability to obtain adequate fundoscopic photos
- Acute intoxication, altered mental status, or head injury within the last 6 months
- Opiate or benzodiazepine administration by treating providers
- Clinical condition not allowing testing.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01815567
||Tamara Espinoza, MD
||Tamara Espinoza, MD, Assistant Professor, Emory University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 20, 2012
||December 21, 2016
Keywords provided by Tamara Espinoza, MD, Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 23, 2017