跳至主要内容
临床试验/NCT02445079
NCT02445079已完成不适用

Epidemiology of Atherosclerosis Among Older-Age People in Southwestern Uganda

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
309
试验地点
1
主要终点
Baseline prevalence and incident change in carotid intima media thickness

研究概览

简要总结

Longitudinal cohort study of older-aged people living with HIV infection in southwestern Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring the epidemiology of cardiovascular and pulmonary disease in this study setting, and particularly the contribution of HIV infection to it.

详细描述

This study recruits people living with HIV/AIDS (PLWH) aged 40 and older; and an HIV-uninfected age and gender-matched, community-based comparison group in the HIV clinic catchment area.

Study investigators will collect sociodemographic, clinical, immune activation, systemic inflammation, plasma and stool microbiome, and clinical pulmonary and cardiovascular disease measures. Our outcomes of interest are measures of carotid atherosclerosis, including carotid intima media thickness and presence of plaque, prior ischemic heart disease (as measured by electrocardiograms), peripheral arterial disease (as measured by ankle-branchial index), and lung function as measured by pulmonary function testing. Our exposures of interest are traditional cardiovascular disease risk factors (e.g. age, gender, family history of cardiovascular disease, smoking history, diet, activity, body mass index, prevalence of diabetes, and prevalence of hypertension) and HIV-related cardiovascular risk factors (e.g. nadir CD4 count, ART duration and regimen, gut and plasma microbiome composition, and markers of both immune activation and systemic inflammation).

Investigators will collect this data to accomplish the following aims:

Aim 1: Compare the prevalence of atherosclerosis, measured by cIMT, ankle-brachial index, and presence of q-waves on electrocardiogram, in PLWH taking ART aged 40 and older and age and gender-matched, population-based HIV-uninfected controls. This study aims to be among the first to capture high-quality measures of atherosclerotic disease among a population of PLWH in sub-Saharan Africa. The study aims to test the hypothesis that older-age Ugandans on ART will have thicker carotid intima media, higher prevalence of peripheral arterial disease, and higher prevalence of pathologic q-waves on electrocardiogram than age and gender-matched, HIV-uninfected controls.

Aim 2: Evaluate correlates of atherosclerosis in older-age PLWH on ART, including both traditional (age, gender, smoking, diabetes and hypertension prevalence) and HIV-related risk factors (immune activation, systemic inflammation, and stool and plasma microbiome composition). The study will leverage a collaboration with the Ragon Institute to perform immunologic and molecular testing for microbial translocation and markers of immune activation and systemic inflammation (e.g. soluble CD163, C-reactive protein, IL-6, CD8+ T-lymphocyte activation).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected
  • Age > 40 years old at enrollment
  • Minimum 2 years of antiretroviral therapy

排除标准

  • Decline informed consent
  • Group 2 Inclusion Criteria:
  • Living in catchment area of Mbarara Regional Referral Hospital (greater Mbarara)
  • Age > 40 years old
  • Age and gender matched to a participant in group 1
  • Group 2 Exclusion Criteria:
  • HIV infection (tested annually as part of study procedures)
  • Decline informed consent

结局指标

主要结局

Baseline prevalence and incident change in carotid intima media thickness

时间窗: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

Measured by carotid ultrasonography

次要结局

  • Baseline prevalence and incident change in carotid plaque(Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months))
  • Baseline prevalence and incident change in ischemic heart disease(Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months))
  • Baseline prevalence and incident change in peripheral arterial disease(Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months))
  • Baseline prevalence and incident change in chronic obstructive pulmonary disease(Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Siedner

Assistant in Medicine

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验