The Microvascular Brain Retina And Kidney Study

Cerebral Small Vessels Disease Clinical Trial

— MICROBREAK2  

Official title:

Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210130
• Other study ID #: AMR_2013-8
• Status: Completed
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 2017
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cerebral Small Vessels Disease

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determinants of CSCV in patients with HIV		baseline