PROFES: Prognosis of a First-Ever Stroke in Persons Living With HIV

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Terminated

CT.gov ID

NCT02748252

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident, Acute HIV	Other: stroke center referral

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
HIV patients HIV patients admitted in Stroke units for the first occurence of acute stroke	Other: stroke center referral
non HIV patients non HIV patients admitted in Stroke units for the first occurence of acute stroke	Other: stroke center referral

Arm

Intervention/Treatment

HIV patients

HIV patients admitted in Stroke units for the first occurence of acute stroke

Other: stroke center referral

non HIV patients

non HIV patients admitted in Stroke units for the first occurence of acute stroke

Other: stroke center referral

Outcome Measures

Primary Outcome Measures

degree of disability measured with the modified Rankin Scale [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT02748252

Other Study ID Numbers:

AMR_2014-3

First Posted:

Apr 22, 2016

Last Update Posted:

Aug 9, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 9, 2018