About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients aged between 18 and 85 years, with an mRS score ≤ 4 and Ischemic stroke classified as ESUS according to standard criteria, with LVD (defined as moderately reduced ejection fraction 30-49%, presence of LC wall motion abnormalities, LV aneurysm, LV dilatation with or without spontaneous echo-contrast, non-compacted LV \[with deep trabeculations or spongy LV\], cardiomyopathies \[severe restrictive cardiomyopathy, cardiac amyloidosis, hypertrophic cardiomyopathy\]), in whom no intracardiac thrombi are identified on transthoracic echocardiogram and who are able to undergo advanced cardiac imaging (CMRI and/or CCT).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of left ventricular thrombus on advanced cardiac imaging (CMRI and/or CCT)
Prevalence of left ventricular thrombus detected by advanced cardiac imaging (CMR, CCT) compared with transthoracic echocardiography (TTE) in patients who underwent both investigations within 15 days of the index stroke
Secondary outcomes
Intracardiac thrombi detected by transthoracic echocardiography in all patients with ESUS and LVD. Recurrent ischemic stroke Systemic embolism Acute coronary events Major bleeding, defined by the International Society of Thrombosis and Hemostasis Mortal
Incidence of major cardiovascular events (MACE) at 12 months
Sponsors and contacts
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