Neurocognitive Decline, Subclinical Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Atherosclerosis, Neurocognitive Decline, Inflammation
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPeripheral Vascular Imaging
Peripheral Vascular Imaging of Carotid and Femoral Arteries by Eco-Doppler Ultrasound
DIAGNOSTIC_TESTCoro-CT
Coronary Computed Axial Tomography (Coro-TC) with contrast administration
DIAGNOSTIC_TESTNeurocognitive Assesment
Study of neurocognitive function and decline by pre-established tests
PROCEDUREBlood Sampling
Blood sampling for further molecular and cellular analysis
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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.
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. Coronary Artery Disease Group Inclusion Criteria: * Age \>= 18 years * Capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima-Media Thickness (cIMT) (mm) | 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) | 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) | 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. |
Countries
Italy
Outcome results
None listed