HIV Infection And Evolvement of Atherosclerotic Plaque

Summary

In a prospective multi-center observational study, 200 HIV-infected patients treated with antiretroviral treatment (ART) and who suffered from coronary artery disease (CAD) will be enrolled. Blood samples for biological parameters will be collected with all participants: lipid profile and markers of systemic inflammation specific for HIV-infection (lipopolysaccharide-binding protein; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP).

All of them will undergo functional testing (Echo, CMR both at rest and stress if necessary) and invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS.

Patients will be treated according to the current and previous recommendations. Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be done.

Collected data will be analyzed: correlation between ART, blood test results, coronary angiography results, including performed PTCA, history of myocardial infarctions, and other cardiovascular events.

The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up.

The independent ethics expertise will be provided by the Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging will be provided by The Ethics Board of Central Clinical Hospital of the Russian Academy of Sciences.

Conditions

• Coronary Artery Disease
• Atherosclerosis, Coronary
• Hiv
• HIV Infections
• Stable Chronic Angina

Interventions

RADIATION

Quantitative coronary angiography, intravascular imaging with percutaneous intervention

Coronaries will be shot with AXIOM Artis dFC (Siemens, Munich,Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) and/ or percutaneous intervention (with implantation of the medical device).

Sponsors & Collaborators

• Moscow Regional Centre For HIV Care and Prevention

  collaborator UNKNOWN

• Central Clinical Hospital of the Russian Academy of Sciences

  lead OTHER_GOV

Principal Investigators

• Diana Izimarieva, MD · Central Clinical Hospital of the Russian Academy of Sciences

• Elena Orlova-Morozova, MD, PhD · Moscow Regional Centre For HIV Care and Prevention

• Alexey Sozykin, MD, D.Sc · Central Clinical Hospital of the Russian Academy of Sciences

• Alexey Nikitin, M.D., D.Sc., Ph.D. · Central Clinical Hospital of the Russian Academy of Sciences

• Eugene Averin, M.D., D.Sc., Ph.D. · Central Clinical Hospital of the Russian Academy of Sciences

• Alexey Shevchenko, M.D., D.Sc., Ph.D. · Pirogov Russian National Research Medical University

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-05

Primary Completion

2022-12-05

Completion

2023-12-05

Countries

• Russia

Study Locations