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NCT Number: NCT07520643

MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling

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.

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Key information

Conditions

Subclinical Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Inflammation Neurocognitive Decline Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Peripheral Vascular Imaging

Diagnostic Test

Peripheral Vascular Imaging of Carotid and Femoral Arteries by Eco-Doppler Ultrasound

Coro-CT

Diagnostic Test

Coronary Computed Axial Tomography (Coro-TC) with contrast administration

Neurocognitive Assesment

Diagnostic Test

Study of neurocognitive function and decline by pre-established tests

blood sampling

Procedure

Blood sampling for further molecular and cellular analysis

Primary outcomes

  1. Carotid Intima-Media Thickness (cIMT) (mm)

    Time frame: 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).

  2. Agatston Score (RU)

    Time frame: 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

  3. Montreal cognitive assessment (MoCA) test (points)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: MISTIC

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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