DETECT and Retinal Outcomes in Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 23, 2014
Last verified: May 2014

September 20, 2012
May 23, 2014
November 2012
June 2015   (final data collection date for primary outcome measure)
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 ] [ 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 Emergency Department presentation. Subjects will not be followed after their initial enrollment. The study duration is projected for 12 months

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

Complete list of historical versions of study NCT01815567 on ClinicalTrials.gov Archive Site
Variance of DETECT scores (Z-score) attributed to reading level [ Time Frame: One year study periord (12 months) ] [ Designated as safety issue: No ]
Variance of DETECT scores (Zscore) attributed to reading level [ Time Frame: One year study periord (12 months) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

The purpose of this study is to study the impact of blood pressure on cognitive performance.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Emergency department patients that meet the inclusion/exclusion criteria.

  • Hypertension
  • Retinal Disorder
  • Cognitive Impairment
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Tamara Espinoza, MD tamara.espinoza@emory.edu
Contact: David W Wright, MD dwwrigh@emory.edu
United States
 
NCT01815567
IRB00060043
No
Tamara Espinoza, MD, Emory University
Emory University
Not Provided
Principal Investigator: Tamara Espinoza, MD Emory University
Emory University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP