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DETECT and Retinal Outcomes in Hypertension

This study is currently recruiting participants.
Verified March 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01815567
First received: September 20, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • DETECT neurocognitive outcome scores (Zscores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ED 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 (Zscore) attributed to reading level [ Time Frame: One year study periord (12 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tamara Espinoza, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01815567     History of Changes
Other Study ID Numbers: IRB00060043
Study First Received: September 20, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Hypertension
Retinal Disorder
Cognitive impairment

Additional relevant MeSH terms:
Hypertension
Retinal Diseases
Cognition Disorders
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013