Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients (MICROBREAK1)
|ClinicalTrials.gov Identifier: NCT02082574|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : October 21, 2016
Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.
The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.
500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2*).
Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.
We are expecting to prove that CSVD is more frequent in HIV+ population.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||655 participants|
|Observational Model:||Case Control|
|Official Title:||Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 2016|
HIV infected for more than 5 years, aged over 50, treated with ARV
non HIV (matched for age and gender)
- Cerebral small vessel disease [ Time Frame: baseline ]Cerebral small vessel disease detected with MRI
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082574
|Fondation Ophtalmologique Adolphe de Rothschild|
|Paris, Ile de France, France, 75019|
|Principal Investigator:||Antoine MOULIGNIER, Dr||Fondation Ophtalmologique Adolphe de Rothschild|