Prognosis of a First-Ever Stroke in Persons Living With HIV
PROFES
1 other identifier
observational
4
1 country
1
Brief Summary
With aging of the persons living with HIV, cardiovascular diseases now account for substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age. The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance. It would also be important to know whether HIV patients need specific protocols for stroke emergency management. The study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 9, 2018
August 1, 2018
Same day
April 18, 2016
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
degree of disability measured with the modified Rankin Scale
3 months
Study Arms (2)
HIV patients
HIV patients admitted in Stroke units for the first occurence of acute stroke
non HIV patients
non HIV patients admitted in Stroke units for the first occurence of acute stroke
Interventions
Eligibility Criteria
patients admitted to a Stroke Unit for the first occurrence of an ischemic stroke
You may qualify if:
- Patients unexposed to HIV: HIV-1 seronegative OR patients exposed to HIV: HIV seropositive for over 6 months with or without antiretroviral treatment. Confirmed by Elisa and Western blot tests
- admitted for ischemic stroke, defined as a sudden cerebrovascular event confirmed by MRI
- at least 18 years of age
- paired with patients unexposed to HIV, admitted for ischemic stroke, same gender and age
You may not qualify if:
- antecedents of a symptomatic ischemic or hemorrhagic cerebrovascular event
- no social security benefits;
- Absence of signed informed consent for the study
- Patients currently pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 22, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
August 9, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share