Actively Recruiting
Cardiac Assessment for Thrombus Detection in the Heart Using Advanced Imaging (MRI, CT) in ESUS With Left Ventricular Disease
Led by Niguarda Hospital · Updated on 2025-12-23
125
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The CATCH ME study is a prospective, multicenter, observational, no-profit study aimed at improving embolic risk stratification in patients with embolic stroke of undetermined source (ESUS), particularly in those with left ventricular disease (LVD). LVD is defined by a mildly to moderately reduced ejection fraction (30-49%), left ventricular wall motion abnormalities (hypo/akinesia), ventricular dilation, cardiomyopathies, and other related conditions. In these patients, the intermittent formation of intracardiac thrombi within the ventricle, often undetectable by standard diagnostic evaluation such as transthoracic echocardiography (TTE) alone, may serve as an unrecognized embolic source. However, in clinical practice, such patients are frequently discharged on antiplatelet therapy alone, without adequate thromboembolic risk stratification, thus leaving them at a high risk of ischemic recurrence. This study aims to assess the additional diagnostic value of advanced cardiac imaging - Cardiac Magnetic Resonance Imaging (CMRI) and/or Cardiac Computed Tomography (CCT) - in detecting intracardiac thrombi not identified by TTE in patients with ESUS and LVD.
CONDITIONS
Official Title
Cardiac Assessment for Thrombus Detection in the Heart Using Advanced Imaging (MRI, CT) in ESUS With Left Ventricular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Modified Rankin Scale (mRS) score 4
- Diagnosis of acute ischemic stroke confirmed by CT or brain MRI
- Diagnosis of embolic stroke of undetermined source (ESUS) using standard criteria
- Stroke is not lacunar (small subcortical infarction 1.5 cm on CT or 2.0 cm on diffusion-weighted MRI)
- No extracranial or intracranial artery stenosis 6% in the artery supplying the affected area
- No major cardioembolic source including permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus (except isolated ventricular thrombus), mechanical heart valve, atrial myxoma, moderate/severe mitral stenosis, recent myocardial infarction ( 4 weeks), valve vegetations, or infective endocarditis
- No other identified cause of stroke such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability
- Presence of left ventricular disease defined by at least one: EF 30-49%, left ventricular wall motion abnormalities not related to recent infarction, left ventricular aneurysm, enlarged left ventricle, non-compacted left ventricle, or cardiomyopathies including restrictive, hypertrophic, or cardiac amyloidosis
- Ability to sign informed consent or recruitment in deferred mode if unconscious without legal representative
You will not qualify if you...
- Presence of major cardioembolic sources as defined in the ESUS criteria
- Thrombophilic state secondary to active cancer diagnosed within 6 months, ongoing cancer treatment, or hematologic cancer not in remission
- Ipsilateral carotid plaques at high risk such as thrombus, floating thrombus, or ulcerated plaque
- Patients under 60 years old with high-risk patent foramen ovale (PFO) and probable PFO-associated stroke
- Pregnancy or puerperium
- Contraindications to MRI or CT with contrast agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy, 20162
Actively Recruiting
Research Team
A
Angelo Cascio Rizzo, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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