Multilevel and Interdisciplinary Assessment of Subclinical to Clinical Atherosclerosis Interactions With Neurocognitive Function and Cardiovascular System Through Endothelial and Inflammatory Cell Signalling: The MISTIC Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Carotid Intima-Media Thickness (cIMT) (mm)
研究概览
简要总结
The MISTIC study is a non-profit, cross-sectional clinical research project aimed at investigating the relationship between atherosclerosis and both cardiovascular and cognitive function in adult populations.
Atherosclerosis is a progressive condition characterized by the accumulation of material within arterial walls, leading to vascular narrowing and impaired blood flow. While its most recognized consequences are acute events such as myocardial infarction or stroke, earlier stages of the disease, often asymptomatic, may already be associated with functional changes affecting multiple organ systems.
This study focuses on evaluating the association between vascular health and cognitive performance at a single time point. Atherosclerotic burden will be assessed using non-invasive imaging techniques, including carotid intima-media thickness and coronary calcium scoring. Cognitive performance will be measured using standardized neuropsychological tests.
Approximately 1000 participants will be enrolled and divided into two groups: a control group without clinically established cardiovascular disease, and a group of patients with coronary artery disease (CAD). All participants will undergo clinical evaluation, vascular imaging, cognitive testing, and analysis of biological samples.
The primary objective is to determine whether increasing atherosclerotic burden is associated with measurable differences in cognitive and cardiovascular function. Secondary aims include identifying patterns that may help improve early detection and risk stratification of vascular disease.
The results of this study are expected to contribute to a better understanding of atherosclerosis as a systemic condition and to support the development of preventive strategies targeting early stages of vascular disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control Group
- •Inclusion Criteria:
- •Age >= 18 years
- •Capacity to provide informed consent
- •Documented coronary artery stenosis ≥ 50 % through peripheral vascular ultrasound imaging.Documented coronary artery stenosis ≥ 50 % through peripheral vascular ultrasound imaging.
排除标准
- •Prior ischemic cardiac events (e.g., myocardial infarction, unstable angina).
- •Major electrophysiological disorders.
- •History of stroke or transient ischemic attack.
- •Ongoing renal replacement therapy (dialysis).
- •Use of systemic immunosuppressive or anti-inflammatory medications (beyond low-dose aspirin).
- •Any chronic inflammatory or autoimmune disease.
- •Active infectious disease at the time of enrolment.
- •Active malignancy or cancer treatment within the past 5 years.
- •Coronary Artery Disease Group
- •Inclusion Criteria:
- •Age >= 18 years
- •Capacity to provide informed consent
- •Exclusion Criteria:
- •Prior ischemic cardiac events (e.g., myocardial infarction, unstable angina).
- •Major electrophysiological disorders.
- •History of stroke or transient ischemic attack.
- •Ongoing renal replacement therapy (dialysis).
- •Use of systemic immunosuppressive or anti-inflammatory medications (beyond low-dose aspirin).
- •Any chronic inflammatory or autoimmune disease.
- •Active infectious disease at the time of enrolment.
- •Active malignancy or cancer treatment within the past 5 years.
研究组 & 干预措施
Patients with Coronary Artery Disease
干预措施: Peripheral Vascular Imaging (Diagnostic Test)
Patients with Coronary Artery Disease
干预措施: Coro-CT (Diagnostic Test)
Patients with Coronary Artery Disease
干预措施: Neurocognitive Assesment (Diagnostic Test)
Patients with Coronary Artery Disease
干预措施: Blood Sampling (Procedure)
Control Individuals
干预措施: Peripheral Vascular Imaging (Diagnostic Test)
Control Individuals
干预措施: Coro-CT (Diagnostic Test)
Control Individuals
干预措施: Neurocognitive Assesment (Diagnostic Test)
Control Individuals
干预措施: Blood Sampling (Procedure)
结局指标
主要结局
Carotid Intima-Media Thickness (cIMT) (mm)
时间窗: From enrollment to the end of diagnostic tests at 6 months
The Carotid Intima-Media Thickness (cIMT) is a non-invasive ultrasound measurement used to assess the thickness of the inner two layers (intima and media) of the carotid artery wall. It is commonly used as a marker of subclinical atherosclerosis and cardiovascular risk. The measurement is typically obtained from the common carotid artery using high-resolution B-mode ultrasound. Increased cIMT values are associated with a higher risk of cardiovascular events such as stroke and myocardial infarction. cIMT is measured in millimeters (mm).
Agatston Score (RU)
时间窗: From enrollment to the end of treatment at 6 months
The Agatston Score is a quantitative measure of coronary artery calcification obtained from non-contrast cardiac CT scans. It is used to estimate the burden of coronary atherosclerosis and predict the risk of future cardiovascular events. The score is calculated by identifying areas of radiodense (hyperdense) calcium in the coronary arteries (attenuation ≥130 Hounsfield units), multiplying the area by a density factor, and summing the results across all coronary arteries. The Agatston Score is expressed in Agatston Units (AU). It is a dimensionless index, not a physical unit, even though it is sometimes abbreviated as "RU" (risk units) in some contexts. 0 AU → no detectable calcification 1-99 AU → mild calcification 100-399 AU → moderate calcification ≥400 AU → extensive calcification
Montreal cognitive assessment (MoCA) test (points)
时间窗: From enrollment to the end of treatment at 6 months
The Montreal Cognitive Assessment (MoCA) is a brief screening tool used to detect mild cognitive impairment and early dementia. It evaluates multiple cognitive domains, including: Attention and concentration, Executive functions, Memory (delayed recall), Language, Visuospatial skills, Abstraction and Orientation. The test typically takes about 10 minutes to administer and consists of a series of short tasks (e.g., word recall, clock drawing, naming, and serial subtraction). The MoCA is scored as a total point-based scale, with a maximum of 30 points. Scores are expressed simply as "points" (no physical units). A score of 26 or above (≥26/30) is generally considered normal, although this may vary with age and education.
次要结局
未报告次要终点
研究者
Liuzzo Giovanna
Medical Doctor, Cardiologist - Head of the Acute Coronary Syndromes Unit - Head of the Molecular and Cellular Cardiology Laboratory
Fondazione Policlinico Universitario Agostino Gemelli IRCCS