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DETECT and Retinal Outcomes in Hypertension

This study is currently recruiting participants.
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Verified December 2016 by Tamara Espinoza, MD, Emory University
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University Identifier:
First received: September 20, 2012
Last updated: December 21, 2016
Last verified: December 2016
The purpose of this study is to study the impact of blood pressure on cognitive performance.

Hypertension Retinal Disorder Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events

Further study details as provided by Tamara Espinoza, MD, Emory University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Variance of DETECT scores (Z-score) attributed to reading level [ Time Frame: One year study periord (12 months) ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Emergency department patients that meet the inclusion/exclusion criteria.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01815567

Contact: Tamara Espinoza, MD
Contact: David W Wright, MD

United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Tamara Espinoza, MD   
Sponsors and Collaborators
Emory University
Principal Investigator: Tamara Espinoza, MD Emory University
  More Information

Responsible Party: Tamara Espinoza, MD, Assistant Professor, Emory University Identifier: NCT01815567     History of Changes
Other Study ID Numbers: IRB00060043
Study First Received: September 20, 2012
Last Updated: December 21, 2016

Keywords provided by Tamara Espinoza, MD, Emory University:
Retinal Disorder
Cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Retinal Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders
Eye Diseases processed this record on August 23, 2017