Hypertension Clinical Trial
Official title:
The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events
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 |
Verified date | May 2021 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to study the impact of blood pressure on cognitive performance.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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