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The Microvascular Brain Retina And Kidney Study (MICROBREAK2)

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ClinicalTrials.gov Identifier: NCT02210130
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:

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 Design
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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
patients HIV+ CSVD+
patients with HIV and cerebral small vessel disease
control HIV+ CSVD-
patients with HIV and without cerebral small vessel disease


Outcome Measures
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Primary Outcome Measures :
  1. determinants of CSCV in patients with HIV [ Time Frame: baseline ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy With (patients) or without Cerebral Small Vessels Disease
Criteria

Inclusion Criteria:

  • age over 50 years old
  • chronic HIV seropositive patient infected for at least 5 years
  • antiretroviral therapy
  • plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
  • cerebral small vessels disease (patients) or not (controls)

Exclusion Criteria:

  • Co-infection VHC
  • known antecedent of stroke
  • documented neurologic complication of HIV
  • drug user
  • glomerular filtration rate< 15 mL/mn
  • diabetic patient with kidney or retin complications
  • systolic blood pressure≥ 180 and/or diastolic blood pressure≥ 110 mmHg
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Ile De France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
French National Agency for Research on AIDS and Viral Hepatitis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02210130    
Other Study ID Numbers: AMR_2013-8
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases