HypertensionNCT01815567
DETECT and Retinal Outcomes in Hypertension
An observational study of Hypertension and Retinal Disorder, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to study the impact of blood pressure on cognitive performance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Retinal Disorder, Cognitive Impairment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency department patients that meet the inclusion/exclusion criteria.
Who may be able to join
- 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 -
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.
- Conditions
- Hypertension, Retinal Disorder, Cognitive Impairment
- Keywords
- Hypertension, Retinal Disorder, Cognitive impairment
- Medical subject headings
- Hypertension, Retinal Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy)
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
Measured: 12 months
Secondary outcomes (1)
Variance of DETECT scores (Z-score) attributed to reading level
Measured: One year study periord (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startNov 2012
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Espinoza, MD, Emory University
- Investigators
- Tamara Espinoza, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815567
- Sponsor's protocol ID
- IRB00060043
- Status last verified
- May 2021
- First submitted
- 20 Sep 2012
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events
- ClinicalTrials.gov ID
- NCT01815567
- Acronym / sponsor ID
- IRB00060043
- Conditions
- Hypertension, Retinal Disorder, Cognitive Impairment
- Keywords
- Hypertension, Retinal Disorder, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the impact of blood pressure on cognitive performance.
Detailed description
Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients that meet the inclusion/exclusion criteria.
Key inclusion criteria (9 listed)
- 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:
- 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
- Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Variance of DETECT scores (Z-score) attributed to reading level
Time frame: One year study periord (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Espinoza, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Retinal Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.