中年亚临床动脉粥样硬化与大脑健康:PESA-脑研究的原理和设计。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-09-24 DOI:10.1016/j.ahj.2024.09.028
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引用次数: 0

摘要

理由据报道,认知能力下降和痴呆症与动脉粥样硬化有关,而动脉粥样硬化是心血管疾病的主要原因。有必要开展队列研究,确定与亚临床动脉粥样硬化相关的早期脑部变化,以便在脑损伤出现症状和不可逆转之前了解预防策略的潜力:早期亚临床动脉粥样硬化进展(PESA)研究是一项纵向观察性队列研究,2010 年在西班牙马德里招募了 4184 名无症状的中年人(40-54 岁),以全面了解亚临床动脉粥样硬化随时间推移的发展特点。在此框架下,PESA-Brain 研究旨在确定与中年动脉粥样硬化和心血管风险因素相关的早期大脑结构、功能和血管变化。PESA-脑研究的目标是对1000名参与者进行为期10年的PESA随访,包括全面的神经心理学测试、先进的多模态神经影像学检查和基于血液的神经病理学生物标志物的量化:我们假设,在中年时期,心血管风险因素的存在和亚临床动脉粥样硬化的高负担将与大脑结构、功能和血管的改变、更大的淀粉样蛋白负担和细微的认知障碍有关。我们进一步假设,亚临床动脉粥样硬化与中年时大脑健康状况不佳之间的联系将由脑血管病变和颅内动脉粥样硬化介导:PESA-Brain研究于2020年10月开始,预计将于2024年12月完成:这项研究在揭示健康向疾病转变过程中心血管和大脑变化之间的新型关系方面具有独特的地位,可能对干预和治疗方法产生重要影响。试验注册 - 注册表:clinicaltrials.gov;注册号:NCT01410318;注册号:NCT01410318:NCT01410318;网址:https://clinicaltrials.gov/study/NCT01410318。
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Subclinical atherosclerosis and brain health in midlife: Rationale and design of the PESA-Brain study

Rationale

Cognitive decline and dementia have been reportedly linked to atherosclerosis, the main cause of cardiovascular disease. Cohort studies identifying early brain alterations associated with subclinical atherosclerosis are warranted to understand the potential of prevention strategies before cerebral damage becomes symptomatic and irreversible.

Methods & design

The Progression of Early Subclinical Atherosclerosis (PESA) study is a longitudinal observational cohort study that recruited 4,184 asymptomatic middle-aged individuals (40-54 years) in 2010 in Madrid (Spain) to thoroughly characterize subclinical atherosclerosis development over time. In this framework, the PESA-Brain study has been designed to identify early structural, functional and vascular brain changes associated with midlife atherosclerosis and cardiovascular risk factors. The PESA-Brain study targets 1,000 participants at the 10-year follow-up PESA visit and consists of thorough neuropsychological testing, advanced multimodal neuroimaging, and quantification of blood-based neuropathological biomarkers.

Primary hypothesis

We hypothesize that, in middle-age, the presence of cardiovascular risk factors and a high burden of subclinical atherosclerosis will be associated with structural, functional and vascular brain alterations, greater amyloid burden and subtle cognitive impairment. We further hypothesize that the link between subclinical atherosclerosis and poor brain health in midlife will be mediated by cerebrovascular pathology and intracranial atherosclerosis.

Enrollment dates

The PESA-Brain study started in October 2020 and is estimated to be completed by December 2024.

Conclusion

This study is in a unique position to unveil novel relationships between cardiovascular and brain alterations in the health-to-disease transition, which may have important implications for interventional and therapeutic approaches.
ClinicalTrials.gov identifier: NCT01410318.
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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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