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Silent artery disease linked to brain decline? major study launches

NCT ID NCT07520643

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

The MISTIC study will examine 1000 adults to see if early, symptom-free artery disease is linked to thinking and memory problems. Participants will get non-invasive imaging of their arteries and cognitive tests. This is an observational study, not a treatment trial, aiming to improve early detection of vascular and brain health issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify early signs of artery disease that also affect brain function, leading to better prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease coronary artery disorder Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurocognitive decline Subclinical atherosclerotic cardiovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

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