Cardiac Assessment for Thrombus Detection in the Heart Using Advanced Imaging (MRI, CT) in ESUS With Left Ventricular Disease

Recruiting now

Conditions studied: Cryptogenic Ischemic Stroke

In brief

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.

Key facts

Study ID: NCT07298122
Run by: Niguarda Hospital
People needed: 125
Starts: 2025-09-15
Expected to finish: 2028-12-31
Last updated by the study team: 2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age between 18 and 85 years Modified Rankin Scale (mRS) score ≤ 4 Diagnosis of acute ischemic stroke (detected by CT or brain MRI) Diagnosis of ESUS according to standard criteria
Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical infarction (including pons and mesencephalon) in the distribution of the small penetrating cerebral arteries, with a maximum size ≤ 1.5 cm on CT or ≤ 2.0 cm on diffusion-weighted MRI images (< 1.5 cm on T2-weighted MRI images). Excluded: multiple small deep infarcts, lateral bulb infarcts, cerebellar infarcts, patients with clinical lacunar stroke syndrome and no visible infarction on imaging.
Absence of extracranial or intracranial atherosclerosis causing ≥ 50% stenosis in the artery supplying the ischemic area. Vascular imaging of the extracranial and intracranial vessels is required using angiography, CT angiography (CTA), MR angiography (MRA), or color Doppler ultrasound, at the discretion of the treating physician and local principal investigator.
No major cardioembolic source identified, including permanent or paroxysmal atrial fibrillation (AF), sustained atrial flutter, intracardiac thrombus (*as specified above, these patients will be recruited in phase 1 of the study only if an isolated ventricular thrombus is found without other major cardiac causes), mechanical heart valve prosthesis, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, recent myocardial infarction (< 4 weeks), left ventricular ejection fraction (EF) < 30%, valve vegetations or infective endocarditis.
No other identified cause of stroke (such as arteritis, dissection, migraine, vasospasm, drug abuse, hypercoagulability, etc.)
Presence of LVD defined by at least one of the following criteria:
Moderately reduced left ventricular (LV) systolic function, defined as EF 30-49%.
LV wall motion abnormalities (LVWMAs), defined as hypokinetic, akinetic, or dyskinetic segments of the left ventricular wall not associated with recent or acute myocardial infarction (within 4 weeks).
LV aneurysm
Enlarged LV with or without spontaneous contrast
Non-compacted LV, with deep trabeculations or spongy LV
Cardiomyopathies, such as restrictive cardiomyopathy, hypertrophic cardiomyopathy, or cardiac amyloidosis
Patients capable of signing informed consent (IC) or, in the case of unconscious patients without an authorized legal representative, recruited in a "Deferred" mode

You may not qualify if…

Major cardioembolic sources, as specified in the ESUS criteria Patients with a thrombophilic state secondary to active cancer, defined as "diagnosis of solid or hematologic malignant tumor within 6 months of stroke, ongoing oncological treatment, or hematologic cancer not in remission." Patients with ipsilateral carotid plaques to the ischemic stroke considered at high risk: thrombus on the wall, floating thrombus, ulcerated plaque.
Patients under 60 years of age with a high-risk patent foramen ovale (PFO) and stroke classified as "probable" PFO-associated stroke according to the PASCAL classification.
Pregnancy or puerperium. Contraindication to MRI and CT with contrast agents

Where it is running

ASST Grande Ospedale Metropolitano Niguarda — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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