HIV Infection And Evolvement of Atherosclerotic Plaque — HIVE  

HIV Infections Clinical Trial

Official title: Systemic Inflammation and Progression of Atherosclerosis in HIV Patients Underwent Noninvasive and Invasive Multimodality Imaging

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

HIV, the virus that causes AIDS (acquired immunodeficiency syndrome), is one of the world's most serious health and development challenges. Approximately 38 million people live with HIV, and tens of millions of people have died of AIDS-related causes since the beginning of the epidemic.

However, with increasing access to effective HIV prevention, diagnosis, treatment, and care, including opportunistic infections, HIV infection has transformed from an irreversible terminal illness to chronic disease. Unfortunately, increased life expectancy has increased the risk of other chronic diseases such as cardiovascular diseases (CVD). Actually, CVD has become the most common cause of death in HIV-infected individuals. The risk of myocardial infarction and coronary atherosclerosis prevalence is nearly twice as high in people living with HIV than in the general population. Statins are effective primary prevention for CAD events; however, there are no specific statin use guidelines in HIV. Besides, there is not enough information about systemic inflammation markers and their correlation with atherosclerosis severity.

Nowadays, using invasive imaging, including quantitative coronary angiography with or without further percutaneous coronary intervention, optical coherence tomography/ OCT, intravascular ultrasound/ IVUS, VH-IVUS, near-infrared spectroscopy/ NIRS, cardiovascular events can be predicted and prevented.

In a prospective multicenter 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 (Quantitative Coronary Angiography), FFR (Fractional Flow Reserve), QFR (Quantitative Flow Reserve), OCT (Optical Coherence Tomography), IVUS (Intravascular Ultrasound), VH-IVUS (Virtual Histology - IVUS), NIRS (Near Infrared Spectroscopy).

Patients will be treated according to the current and previous recommendations: The 2019 HIV Russian National Guidelines; EACS Guidelines 2020; The AHA scientific statement Characteristics, Prevention, and Management of Cardiovascular Disease in People Living With HIV A Scientific Statement From the American Heart Association. Circulation 2019; ESC/EACTS Guidelines on Myocardial Revascularization 2018; 2019 Guidelines on Chronic Coronary Syndromes.

Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be provided.

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.

The clinical data of the HIVE trial include information of the complex examination with:

1. invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS,

2. two interviews with the risk factor modification recommendations,

3. blood tests:

• lipid profile (total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, VLDL cholesterol),

• 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),

• biochemical blood test (glucose, asparagine transaminase, alanine transaminase, total bilirubin, creatinine, markers of the myocardium damage (myoglobin, troponin I, creatine kinase, creatine kinase-MB, brain natriuretic peptide - NT-proBNP),

• complete blood count,

4. ECG,

5. Echo,

6. CMR results

The prospective patients will be tested with HeartAge, SCORE, Duke ACC/ AHA, Duke - DCS, Diamond-Forrester - DFM, The Seattle Angina Questionnaire - SAQ, DukeActivity Status Index -DASI, and EQ-5D-5L, scores that are specific for HIV: EuroSida AIDS/Death risk score, FENCE score, CSRFENCE Score. Patients will be screened for the major risk factors and their modification: unhealthy blood cholesterol levels, high blood pressure, smoking, insulin resistance, diabetes, overweight or obesity, lack of physical activity, unhealthy diet, older age, genetic or lifestyle factors, family history of early heart diseases.

The PCI and PTCA will be undergone by the 2020 ESC/EACTS Guidelines on Myocardial Revascularization. The imaging data from non-invasive (CMR, Echo) and invasive (QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS) methods will be handled and analyzed with the expert-level post-processing imaging software (Medis Suite Solutions: MR, XA, QFR, CT, Intravascular, Ultrasound) from Medis Medical Imaging Systems B.V. (Leiden, The Netherlands).

Our study aims to evaluate the severity of coronary atherosclerosis in HIV-patients with CAD and its correlation with markers of systemic inflammation specific for HIV-infection (LBP; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP) and to estimate their value in preventing cardiovascular events. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Angina, Stable
• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Coronary Disease
• Hiv
• HIV Infections
• Infections
• Myocardial Ischemia
• Stable Chronic Angina

• NCT number: NCT04810364
• Study type: Observational [Patient Registry]
• Source: Central Clinical Hospital of the Russian Academy of Sciences
• Status: Enrolling by invitation
• Start date: January 5, 2020
• Completion date: December 5, 2023