DETECT and Retinal Outcomes in Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815567
• Other study ID #: IRB00060043
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Hypertension
• Retinal Diseases
• Retinal Disorder

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)