NCT02748252

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

April 18, 2016

Last Update Submit

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

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

Interventions

HIV patientsnon HIV patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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

Locations