The Microvascular Brain Retina And Kidney Study (MICROBREAK2)
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|ClinicalTrials.gov Identifier: NCT02210130|
Recruitment Status : Unknown
Verified May 2016 by Fondation Ophtalmologique Adolphe de Rothschild.
Recruitment status was: Recruiting
First Posted : August 6, 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 study and describe the CSVD in the HIV+ population by: (1) correlating the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular disease.
HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same work-up.
We are expecting to show the relationship between CSVD and cardiovascular risk factors in order to propose specific prevention. We will correlate the CSVD with the neurologic and cognitive function as it is already proved in the general population. We will correlate the CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap screening tools for the CSVD in the HIV+ population.
|Condition or disease|
|Cerebral Small Vessels Disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
patients HIV+ CSVD+
patients with HIV and cerebral small vessel disease
control HIV+ CSVD-
patients with HIV and without cerebral small vessel disease
- determinants of CSCV in patients with HIV [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210130
|Fondation Ophtalmologique Adolphe de Rothschild||Recruiting|
|Paris, Ile de France, France, 75019|
|Contact: Antoine Moulignier, MD email@example.com|
|Principal Investigator: Antoine Moulignier, MD|