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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01815567
Other study ID # IRB00060043
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2012
Est. completion date July 15, 2020

Study information

Verified date May 2021
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to study the impact of blood pressure on cognitive performance.


Description:

Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.


Recruitment information / eligibility

Status Completed
Enrollment 234
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients triaged to the Grady Memorial Hospital Emergency Department or Marcus Trauma Unit 2. Age >18 and <65 3. 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 - 4. 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 - OR - 5. Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension. Exclusion Criteria: 1. Non-English speaking 2. Pre-visit cognitive impairment 3. Physical or psychological impairments that would prohibit comprehension and completion of DETECT testing 4. Inability to obtain adequate fundoscopic photos 5. Acute intoxication, altered mental status, or head injury within the last 6 months 6. Opiate or benzodiazepine administration by treating providers 7. Clinical condition not allowing testing.

Study Design


Locations

Country Name City State
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy) 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
12 months
Secondary Variance of DETECT scores (Z-score) attributed to reading level One year study periord (12 months)
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