- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01815567
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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 -
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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy)
Tidsramme: 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 |
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Variance of DETECT scores (Z-score) attributed to reading level
Tidsramme: One year study periord (12 months)
|
One year study periord (12 months)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tamara Espinoza, MD, Emory University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00060043
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forhøjet blodtryk
-
BayerAfsluttet
-
National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldAfsluttetIdiopatisk pulmonal arteriel hypertension | Kronisk tromboembolisk pulmonal hypertensionDet Forenede Kongerige
-
University of Kansas Medical CenterRekrutteringPulmonal arteriel hypertension | Pulmonal hypertension | Kronisk tromboembolisk pulmonal hypertension | Pulmonal hypertension på grund af venstre hjertesygdom | Pulmonal hypertension, primær, 4 | Pulmonal hypertension, primær, 2 | Pulmonal hypertension, primær, 3 | Pulmonal hypertension, primær | Pulmonal...Forenede Stater
-
University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
-
Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
-
Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertension, essentielForenede Stater
-
Vanderbilt University Medical CenterJohns Hopkins UniversityAfsluttetPulmonal arteriel hypertension | Idiopatisk pulmonal arteriel hypertension | Associeret pulmonal arteriel hypertension | Arvelig pulmonal arteriel hypertensionForenede Stater