HIV Infection And Evolvement of Atherosclerotic Plaque

NCT04810364 | Unknown DMC

• 1 other identifier: HIVE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Coronary Angiography; Echocardiography; Markers of Inflammation; Lipid Profile; Percutaneous transluminal coronary angioplasty; Percutaneous coronary intervention; Coronary Artery Diseases; Atherosclerosis; HIV; Plaque burden; SYNTAX score; Fractional flow reserve; Optical coherence tomography; Intravascular ultrasound; Intravascular imaging

Outcome Measures

Primary Outcomes (4)

• Change of per cent of plaque burden from baseline to follow-up as assessed by QCA

  Plaque burden for both culprit and non-culprit lesions will be calculated as a lesion volume (vessel volume-lumen volume)/lumen volume x 1 00. The progression of atherosclerosis and plaque composition in patients receiving different antiretroviral medications will be quantitatively characterized by the parameters of the lesions. The imaging data will be handled with the expert-level post-processing software.

  At 12 months after the baseline imaging procedure

• Number of participants with major adverse cardiac events that are related to plaque burden

  The composite of cardiac death, cardiac arrest, myocardial infarction, acute coronary syndrome, revascularization by coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI), or rehospitalization for angina for patients with both culprit- and non-culprit-lesion-related events. Event rates will be determined at: hospital, at 12months.

  At 12 months after the baseline imaging procedure

• Diagnostic value of systemic inflammation markers for risk stratification

  To determine prognostic value of systemic inflammation markers (LBP, Lipopolysaccharide binding protein, μg/mL; cytokines: IL-1β, pg/mL; IL-6, pg/mL; IL-8, pg/mL; IL-10, pg/mL; TNF-α, pg/mL; INF-γ, pg/mL; INF-α, pg/mL; procalcitonin, pg/L; inflammatory hsCRP, mg/L) to predict cardiovascular events in patients with HIV.

  At 12 months after the blood testing and the baseline imaging procedure

• Invasive assessment of fractional flow reserve for risk stratification

  To determine the prognostic value of FFR (fractional flow reserve) when below 0.75-0.80 in comparison with the relevant invasive results of QCA (quantitative coronary angiography), QFR (quantitative flow reserve), OCT (optical coherence tomography), IVUS (intravascular ultrasound), VH-IVUS (virtual histology IVUS), NIRS (near-infrared spectroscopy) handled with the expert-level postprocessing software for predicting cardiac death and nonfatal myocardial infarction.

  At 12 months after the baseline imaging procedure

Secondary Outcomes (9)

• Change of serologic marker of inflammation CRP from baseline to follow-up

  At 12 months after the baseline imaging procedure

• Number of participants with procedural success

  At 12 months after the baseline imaging procedure

• Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score I

  At 12 months after the baseline imaging procedure

• Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score II

  At 12 months after the baseline imaging procedure

• Change of fractional flow reserve (FFR) from baseline to follow-up that are related to the progress of atherosclerosis

  At 12 months after the baseline imaging procedure

Study Arms (1)

All HIV-positive patients with chronic coronary syndrome

The Group includes all HIV-positive patients with stable chest pain. The progression of atherosclerosis will be quantitatively characterized by the parameters of the lesions (e.g. plaque burden, cap thickness, arterial remodeling, presence of erosions or rupture, malaposition of the stent, a vessel injury score, etc.). The imaging data will be handled with expert-level post-processing software.

Radiation: Quantitative coronary angiography, intravascular imaging with percutaneous intervention

Interventions

Quantitative coronary angiography, intravascular imaging with percutaneous intervention RADIATION

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).

Also known as: QCA, Coronary intravascular imaging

All HIV-positive patients with chronic coronary syndrome

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All stable chest pain comers with a chronic coronary syndrome without acute angina who underwent QCA, applicable intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) with or without further PCI.

You may qualify if:

• all HIV-positive patients with chronic coronary syndrome or angina equivalent consistent with the manifestation of the stable coronary artery disease (in accordance with the 2019 Guidelines on Chronic Coronary Syndromes);
• patients who underwent CCTA (index procedure) with or without further PCI;
• age above 21 years old;
• patients must receive antiretroviral medications (in accordance to the 2019 HIV Russian National Guidelines; EACS Guidelines 2020);
• lesions may be either de novo or restenotic;
• patient must have one or two-vessel disease in a native coronary vessel requiring or not requiring PCI without indications for immediate bypass surgery with any SYNTAX score;
• successful uncomplicated PCI could be performed in the culprit vessels and all culprit lesions, but there should be no events or complications between the procedures of PCI in the past and 6 months prior to admission to the Chest Pain Center
• the non-culprit vessel should have no flow-limiting lesions (diameter stenosis \<39%, but any plaque burden) and must be available for imaging.The non-culprit vessel must be considered safe for imaging evaluation;

You may not qualify if:

• any acute comorbidities;
• patient has had a documented ST-elevation acute myocardial infarction within the 24 hours prior to admission to the Chest Pain Center;
• unprotected left main lesion location;
• culprit lesion is located within or distal to an arterial or saphenous vein graft;
• untreated significant coronary lesion with a \>50-75% diameter stenosis remaining in the culprit vessel after the planned intervention (branch stenosis is permitted);
• lesion or vessel contains visible thrombus within the imaging procedure;
• patient has an additional lesion that requires intervention within 180 days after the initial hospitalization;
• any diameter stenosis more than 75% in the non-culprit vessel;
• indications for immediate bypass surgery within one year of enrollment with the SYNTAX above 34 (multi-vessel disease requiring intervention in all three major coronary arteries);
• creatinine \>150 mmol/L;
• need for dialysis;
• severe endocrine disorders (diabetes is permitted) including pre-existing thyroid diseases;
• decompensated hypotension or heart failure requiring intubation, inotropes,intravenous diuretics, or intra-aortic balloon counterpulsation;
• patient has a known hypersensitivity, allergy, or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine, or to contrast that cannot be adequately pre-medicated;
• presence of cardiac implants;

Sponsors & Collaborators

• Central Clinical Hospital of the Russian Academy of Sciences: lead
• Moscow Regional Centre For HIV Care and Prevention: collaborator

Study Sites (2)

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

Moscow Regional Centre For HIV Care and Prevention

Moscow, 129110, Russia

Location

Related Links

• Central Clinical Hospital of The Russian Academy of Sciences
• Moscow Regional Centre of HIV Care and Prevention

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to test the main hypothesis

MeSH Terms

Conditions

Coronary Artery Disease; Acquired Immunodeficiency Syndrome; HIV Infections; Angina, Stable; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Izimarieva, MD

  Central Clinical Hospital of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Elena Orlova-Morozova, MD, PhD

  Moscow Regional Centre For HIV Care and Prevention

  STUDY DIRECTOR

• Alexey Sozykin, MD, D.Sc

  Central Clinical Hospital of the Russian Academy of Sciences

  STUDY CHAIR

• Alexey Nikitin, M.D., D.Sc., Ph.D.

  Central Clinical Hospital of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Eugene Averin, M.D., D.Sc., Ph.D.

  Central Clinical Hospital of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Alexey Shevchenko, M.D., D.Sc., Ph.D.

  Pirogov Russian National Research Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 23, 2021
• Study Start: January 5, 2020
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

RU (2)