HIV Infection And Evolvement of Atherosclerotic Plaque
Unknown statusNCT04810364
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Systemic Inflammation and Progression of Atherosclerosis in HIV Patients Underwent Noninvasive and Invasive Multimodality Imaging
- Conditions
- Coronary Artery Disease
- Atherosclerosis, Coronary
- Hiv
- HIV Infections
- Stable Chronic Angina
- Interventions
- Radiation: Quantitative coronary angiography, intravascular imaging with percutaneous intervention
- Sponsor
- Central Clinical Hospital of the Russian Academy of Sciences
- Collaborators
- Moscow Regional Centre For HIV Care and Prevention
- Start date
- 2020-01-05
- Primary completion
- 2022-12-05
- Sex
- All
- Age range
- from 21 Years
- Results posted
- No results posted in this snapshot
- Countries
- Russia
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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; Exclusion Criteria: * 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 ticlopid…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04810364