MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
The study includes 1000 participants recruited at Fondazione Policlinico Gemelli: 500 patients with advanced atherosclerosis undergoing PCI with ≥50% stenosis or documented coronary artery disease, and 500 control subjects from the Primary Cardiovascular Prevention Clinic with indications for CAC scoring, without prior acute coronary events. About 22% of controls may have subclinical atherosclerosis. Cognitive impairment is expected in 12-20% of patients and 4-10% of controls. All participants will undergo a single-timepoint assessment including clinical, imaging, molecular, and neurocognitive evaluations to study the association between vascular burden and cognitive function.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Peripheral Vascular Imaging
Diagnostic testPeripheral Vascular Imaging of Carotid and Femoral Arteries by Eco-Doppler Ultrasound
Coro-CT
Diagnostic testCoronary Computed Axial Tomography (Coro-TC) with contrast administration
Neurocognitive Assesment
Diagnostic testStudy of neurocognitive function and decline by pre-established tests
Blood Sampling
Procedure/SurgeryBlood sampling for further molecular and cellular analysis
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Control Individuals4 interventions
Group B: Patients with Coronary Artery Disease4 interventions
Trial outcomes
Primary outcomes
1
Carotid Intima-Media Thickness (cIMT) (mm)
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).
Time frame
From enrollment to the end of diagnostic tests at 6 months2
Agatston Score (RU)
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
Time frame
From enrollment to the end of treatment at 6 months3
Montreal cognitive assessment (MoCA) test (points)
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.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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