Coronary Artery Calcium Score in People Living With HIV: the French HIV-CAC Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 689
- 主要终点
- Computed tomography coronary artery calcium (CAC) score using the Agatston score
研究概览
简要总结
Clinical study:
- Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk. No study specific interventions were performed.
- Participants: consecutively recruited at two large public hospitals in Paris and Annecy, France where participants were referred for routine cardiac risk stratification.
- Recruitment: was from June 2013 until April 2016.
- Data: anonymous study data were collected during the ambulatory visit. No follow-up was conducted.
Study objectives:
- Primary: compare coronary artery calcification (CAC) score between PLHIV and HIV- in order to bridge gaps in current knowledge.
- Secondary: assess parameters linked to CAC score including predictors and their prevalence, association with carotid/femoral atherosclerosis, and cardiovascular risk scores (ASCVD and HEART score).
Study hypotheses:
- Primary: CAC scores would not be different between PLHIV and HIV-
- Secondary: prevalence of traditional CV risk factors would be lower in PLHIV but that HIV-related nontraditional CV risk factors (including lower grade chronic inflammation, immune dysregulation, and ARV exposure duration) would be associated with higher CAC scores and higher CV risk scores
Study Rational:
- PLHIV have an increased risk of atherosclerotic cardiovascular events compared to the general population. Primary prevention for PLHIV is important but challenging as traditional cardiovascular risk scores do not account for HIV-related factors.
- Computed tomography coronary artery calcium (CAC) score using the Agatston score is useful for detecting and quantifying coronary calcifications. In the general population, CAC score is predictive of future cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent
- •Present one or more cardiovascular risk factor
- •Complete comprehensive cardiovascular assessment including a valid CAC score, vascular evaluation, interview for demographic, clinical and medical history and a medical workup.
排除标准
- •Age younger than 18 years old
- •History of established cardiovascular disease.
结局指标
主要结局
Computed tomography coronary artery calcium (CAC) score using the Agatston score
时间窗: One test was performed between June 2013 and April 2016
The investigators will measure the CAC score using the Agatston score. Agatston score scale: 0 (lowest risk) to \>400 (severely increased risk) Agatston score interpretation: * lower scores mean lower risk * higher scores mean higher risk We will measure Agatston score then assign patients to one of four groups: CAC score = 0; CAC score 1-99, CAC score 100-399, CAC score \> 400
次要结局
- Distribution of cardiovascular risk factors(One assessment was performed between June 2013 and April 2016)
- Rate of carotid and femoral plaques(One assessment was performed between June 2013 and April 2016)
- Distribution of cardiovascular risk scores (ASCVD and HEART score): low, median and high level.(One assessment was performed between June 2013 and April 2016)
研究者
Franck Boccara
Prinicipal Investigator, Senior Cardiologist, Professor of Cardiology
Saint Antoine University Hospital
