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- Klinische proef NCT01109251
Post CVA Persistent Hypertension Caring (Hippocrate)
Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures
The study HIPPOCRATE is a prospective open comparative study with a control group.
The objective of this study is to show that an optimization of the caring of non controlled hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at the follow-up visit, an education of the patient with a decision support tree for the generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better tensional control copared to the usual caring.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study compares the usual follow up of patients seen at a visit three months following the CVA, with a optimised follow up including the tensional auto-measure, the education of the patient and the information of the generalist and the appeal to the AHT multidisciplinary visit for resistant patients, in compliance with the guidelines.
All the hypertended patients able to realise a course of tensional automeasures will be invited to realise a course of tensional auto-measures during three days preceding the visit in the neurology department.
The tensional measures will be performed according the methodology recommended by HAS.
This strategy of caring is conform to the HAS and ESH recommendations regarding the follow up of the hypertended patients.
The hospitalised patients in neurology for CVA are in all cases convocated to the follow up visit three months after the hospitalisation. The patients will be trained in the use of the TAM by the nurse of the neurology depratment before his dropout from the neurology department at the end of hospitalisation.
The systematic use of TAM will allow to identify patients presenting a AHT "white blouse", but too patients presenting masked AHT.
The visit in the neurology department will be performed by the investigators of the neurology department. At the end of this visit, two groups of patients will be identified : patients with a controlled AHT (NI), and patients with a masked or non controlled AHT (MASC + NC).
Patients presenting a controlled AHT or a "white blouse" AHT (NI) will not be randomised. But it will be proposed to them to sign a consent to acquire their agreement to realise a exploitation of their data. This will allow to caracterise better this population of patients.
Patients presenting a masked or non controlled AHT will be invited to participate to the study after signing a consent.
The collection of the consent will be done by the investigators of the neurology department.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Bar Le Duc, Frankrijk, 55000
- Werving
- CH Bar le Duc
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Contact:
- Sébastien RICHARD, MD
- Telefoonnummer: +33 3 83 15 96 82
- E-mail: s.richard@chu-nancy.fr
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Nancy, Frankrijk, 54000
- Werving
- CHU de Nancy
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Contact:
- Jean-Marc BOIVIN, MD,
- Telefoonnummer: +33 3 83 15 73 11
- E-mail: jm.boivin@chu-nancy.fr
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Contact:
- Sanae BOUALI, PhD
- Telefoonnummer: +33 3 83 15 74 38
- E-mail: s.bouali@chu-nancy.fr
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Onderonderzoeker:
- Xavier DUCROCQ, MD, PhD
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Hoofdonderzoeker:
- Jean-Marc BOIVIN
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Onderonderzoeker:
- Patrick ROSSIGNOL
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Onderonderzoeker:
- Sebastien LEFEVRE
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Onderonderzoeker:
- Sébastien RICHARD
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Onderonderzoeker:
- Karine LAVANDIER
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Patient male or female from 20 to 80 years old included.
- ischemic or haemorragic CVA or TIA necessiting an hospitalisation or a consultation in the neurolgy department, from more than 2 months.
- Pression ≥140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥135/85 ou 125/75 (diabetic) = non controlled AHT OR Pression < 140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥ 135/85 ou 125/75 (diabetic) = masked AHT
- Patient agreed to participate to the study and having signed the informed consent from
Exclusion Criteria:
- malignant AHT necessiting the urgent and specialised caring
- Persistance of a carotids bilateral stenosis from more than 70%
- Severe Renal Insufficiency (Creatinin Clearance estimated by the formula MDRD < 30 ml/mn)
CVA with major sequelae which according the judgement of the investigator will not allow to realise TAM :
- Major Cognitive Troubles
- Severe motor Troubles
- Severe concomitant Pathology
- Patient not speaking and not understanding french.
Contre-indications to the realisation of TAM :
- Cardiac Arythmy
- Obese Patients for which the circumference of the arm is > 33 cm
- Patient refusing to go to the 3 months after hospitalisation follow up consultation.
- Patient with no identified generalist
- Patient refusing to sign the informed consent form.
- Absence of affiliation to a Social system.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Intervention group
Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0.
|
All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department. The auto-measures will be performed according the methodology recommended by HAS. |
Ander: Control group
Patients presenting a non controlled AHT(persistent AHT, AHT necessiting an adaptation of the treatment by the generalist) with information of the generalist on the necessity of obtaining the tensional control according the HAS recommendations
|
All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department. The auto-measures will be performed according the methodology recommended by HAS. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
tensional auto-measure
Tijdsspanne: 6 months
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6 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Hippocrate
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Klinische onderzoeken op Post CVA Hypertension
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Rambam Health Care CampusWerving
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Centre Hospitalier Universitaire DijonVoltooid
-
Sheba Medical CenterTel Aviv UniversityOnbekend
-
Centre Hospitalier Universitaire DijonWerving
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AIRx Health, Inc.Stanford UniversityNog niet aan het wervenHypertensie | Beroerte (CVA) of TIAVerenigde Staten
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Kessler FoundationAanmelden op uitnodigingGangwerk, hemiplegie | CVAVerenigde Staten
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Pamukkale UniversityVoltooidTevredenheid, patiënt | Hemiparese; Poststroke/CVAKalkoen
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UGECAM Rhône-AlpesWervingHemiparese; Poststroke/CVAFrankrijk
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Loma Linda UniversityWervingHemiparese; Poststroke/CVAVerenigde Staten
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Reuth Rehabilitation HospitalUniversity of HaifaWervingHemiparese; Poststroke/CVAIsraël