Supplementary Material for: The Missing Link in the Pathophysiology of Vascular Cognitive Impairment: Design of the Heart-Brain Study

Background: Hemodynamic balance in the heart-brain axis
is increasingly recognized as a crucial factor in maintaining
functional and structural integrity of the brain and thereby cognitive
functioning. Patients with heart failure (HF), carotid occlusive disease
(COD), and vascular cognitive impairment (VCI) present themselves with
complaints attributed to specific parts of the heart-brain axis, but
hemodynamic changes often go beyond the part of the axis for which they
primarily seek medical advice. The Heart-Brain Study hypothesizes that
the hemodynamic status of the heart and the brain is an important but
underestimated cause of VCI. We investigate this by studying to what
extent hemodynamic changes contribute to VCI and what the mechanisms
involved are. Here, we provide an overview of the design and protocol. Methods:
The Heart-Brain Study is a multicenter cohort study with a follow-up
measurement after 2 years among 645 participants (175 VCI, 175 COD, 175
HF, and 120 controls). Enrollment criteria are the following: 1 of the 3
diseases diagnosed according to current guidelines, age ≥50 years, no
magnetic resonance contraindications, ability to undergo cognitive
testing, and independence in daily life. A core clinical dataset is
collected including sociodemographic factors, cardiovascular risk
factors, detailed neurologic, cardiac, and medical history, medication,
and a physical examination. In addition, we perform standardized
neuropsychological testing, cardiac, vascular and brain MRI, and blood
sampling. In subsets of participants we assess Alz­heimer biomarkers in
cerebrospinal fluid, and assess echocardiography and 24-hour blood
pressure monitoring. Follow-up measurements after 2 years include
neuropsychological testing, brain MRI, and blood samples for all
participants. We use centralized state-of-the-art storage platforms for
clinical and imaging data. Imaging data are processed centrally with
automated standardized pipelines. Results and Conclusions:
The Heart-Brain Study investigates relationships between
(cardio-)vascular factors, the hemodynamic status of the heart and the
brain, and cognitive impairment. By studying the complete heart-brain
axis in patient groups that represent components of this axis, we have
the opportunity to assess a combination of clinical and subclinical
manifestations of disorders of the heart, vascular system and brain,
with hemodynamic status as a possible binding factor.

背景：心血管-大脑轴的血流平衡日益被视为维持大脑功能和结构完整性的关键因素，进而影响认知功能。患有心力衰竭（HF）、颈动脉闭塞病（COD）和血管性认知障碍（VCI）的患者往往表现出与心血管-大脑轴特定部分相关的症状，但血流动力学变化往往超出了他们最初寻求医疗咨询的轴部分。心脏-大脑研究假定了心脏和大脑的血流状态是VCI的一个重要但尚未充分估计的原因。我们通过研究血流动力学变化在VCI中的贡献程度以及涉及的机制来探讨这一问题。在此，我们概述了研究的设计和方案。方法：心脏-大脑研究是一项多中心队列研究，对645名参与者（175名VCI、175名COD、175名HF和120名对照组）进行了2年后的随访测量。纳入标准如下：根据当前指南诊断为三种疾病之一，年龄≥50岁，无磁共振禁忌症，能够接受认知测试，以及日常生活能力独立。收集核心临床数据集，包括社会经济因素、心血管风险因素、详细的神经学、心脏和医疗史、用药情况以及体格检查。此外，我们还进行标准化神经心理学测试、心脏、血管和脑部MRI以及血液采样。在参与者子集中，我们评估脑脊液中的阿尔茨海默病生物标志物，并评估超声心动图和24小时血压监测。两年后的随访测量包括神经心理学测试、脑部MRI和所有参与者的血液样本。我们使用集中式的先进存储平台存储临床和成像数据。成像数据通过自动标准化流程进行集中处理。结果与结论：心脏-大脑研究探讨（心血管）血管因素、心脏和大脑的血流状态与认知障碍之间的关系。通过研究代表该轴组成部分的患者群体中的完整心脏-大脑轴，我们有机会评估心脏、血管系统和大脑疾病临床和亚临床表现的组合，其中血流状态可能是一个潜在的关联因素。