Cerebrovascular Accident, AcutePROFESNCT02748252
Prognosis of a First-Ever Stroke in Persons Living With HIV
An observational study of Cerebrovascular Accident, Acute and HIV, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Acute, HIV
- What is being tested?
- stroke center referral
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to a Stroke Unit for the first occurrence of an ischemic stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019
About this study
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.
Read more
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.
- Conditions
- Cerebrovascular Accident, Acute, HIV
- Being tested
- stroke center referral
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke center referralOther
| Study group | Role | What they receive |
|---|---|---|
| HIV patients | HIV patients admitted in Stroke units for the first occurence of acute stroke Receives: Other: stroke center referral | |
| non HIV patients | non HIV patients admitted in Stroke units for the first occurence of acute stroke Receives: Other: stroke center referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of disability measured with the modified Rankin Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular Accident, AcuteStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748252
- Sponsor's protocol ID
- AMR_2014-3
- Acronym
- PROFES
- Status last verified
- Aug 2018
- First submitted
- 18 Apr 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of a First-Ever Stroke in Persons Living With HIV
- ClinicalTrials.gov ID
- NCT02748252
- Acronym / sponsor ID
- PROFES / AMR_2014-3
- Conditions
- Cerebrovascular Accident, Acute, HIV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV patients | – | Other: stroke center referralHIV patients admitted in Stroke units for the first occurence of acute stroke |
| non HIV patients | – | Other: stroke center referralnon HIV patients admitted in Stroke units for the first occurence of acute stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to a Stroke Unit for the first occurrence of an ischemic stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stroke center referral | Other | HIV patients, non HIV patients |
Primary outcome
degree of disability measured with the modified Rankin Scale
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, Acute and HIV, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of disability measured with the modified Rankin Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.