Coronary Artery Disease (CAD) in Patients HIV-infected

NCT04579146 | Unknown DMC

• 1 other identifier: 2019-A00219-48
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques

  Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.

  24 months

Secondary Outcomes (1)

• Identify the bacterial populations constituting the intestinal microbiota in patients infected with HIV and look for a microbiotic signature in patients with subclinical atherothrombosis.

  24 months

Study Arms (1)

HIV-1 patients and treated effectively for more than 12 months

X-ray examination with contrast by a 64-slice CT coronary angiography.

Other: coronary computed tomographic angiographic (CCTA)

Interventions

coronary computed tomographic angiographic (CCTA) OTHER

x-ray examination with contrast by a 64-slice CT coronary angiography.

HIV-1 patients and treated effectively for more than 12 months

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient VIH-1

You may qualify if:

• HIV-infected patients \>= 45 years with 2 or more CV risk factors currently on ART HIV-RNA \< 50 copies \>= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months

You may not qualify if:

• Sign of coronary pathology (chest pain, syncope, dyspnea).
• ATCD of allergy to IV contrast agents
• Chronic inflammatory disease other than HIV
• Subject to a measure for the protection of justice

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

BENNANI

Marseille, 13003, France

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 8, 2020
• Study Start: September 7, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)