DETECT and Retinal Outcomes in Hypertension

Completed

• Conditions: Cognitive Impairment; Hypertension; Retinal Disorder

• Registration Number: NCT01815567
• Lead Sponsor: Emory University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-09-20
• Study Start: 2012-11
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy)	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

Name	Time	Method
Variance of DETECT scores (Z-score) attributed to reading level	One year study periord (12 months)

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States