- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815567
DETECT and Retinal Outcomes in Hypertension
The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variance of DETECT scores (Z-score) attributed to reading level
Time Frame: One year study periord (12 months)
|
One year study periord (12 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamara Espinoza, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00060043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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