DETECT and Retinal Outcomes in Hyperten… | Clinical Trial

Key information

Conditions

Hypertension Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Eye Diseases Mental Disorders Neurocognitive Disorders Retinal Diseases Retinal Disorder Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

OR -
Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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 outcomes

Variance of DETECT scores (Z-score) attributed to reading level

Time frame: One year study periord (12 months)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2013
Registry last updated: May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed