DETECT and Retinal Outcomes in Hypertension

NCT01815567 | Completed

• 1 other identifier: IRB00060043
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Retinal Disorder; Cognitive Impairment

Keywords

Hypertension; Retinal Disorder; Cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  One year study periord (12 months)

Study Arms (4)

controlled hypertension

hypertension with medication controlled

uncontrolled hypertension

non-controlled hypertension

hypertensive urgency

hypertensive urgency no previous history or antihypertensives

asymptomatic normotensive

asymptomatic normotensive control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency department patients that meet the inclusion/exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Hypertension; Retinal Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tamara Espinoza, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: March 21, 2013
• Study Start: November 1, 2012
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)