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DETECT and Retinal Outcomes in Hypertension

This study is currently recruiting participants.
Verified December 2016 by Tamara Espinoza, MD, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815567
First Posted: March 21, 2013
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University
  Purpose
The purpose of this study is to study the impact of blood pressure on cognitive performance.

Condition
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)
Groups/Cohorts
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815567


Contacts
Contact: Tamara Espinoza, MD tamara.espinoza@emory.edu
Contact: David W Wright, MD dwwrigh@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Tamara Espinoza, MD       tamara.espinoza@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Tamara Espinoza, MD Emory University
  More Information

Responsible Party: Tamara Espinoza, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01815567     History of Changes
Other Study ID Numbers: IRB00060043
First Submitted: September 20, 2012
First Posted: March 21, 2013
Last Update Posted: December 22, 2016
Last Verified: December 2016

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

Additional relevant MeSH terms:
Hypertension
Cognition Disorders
Retinal Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders
Eye Diseases