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

NCT07298122 | Recruiting DMC

• 1 other identifier: 5684
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cryptogenic Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  15 days from the index stroke

Secondary Outcomes (1)

• 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

  12 months from the index stroke

Study Arms (1)

Embolic stroke of undetermined source with left ventricular disease

Patients with embolic stroke of undetermined source and left ventricular disease, with no intracardiac thrombus identified on transthoracic echocardiography, will undergo advanced cardiac imaging such as cardiac MRI and/or CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

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

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Angelo Cascio Rizzo, MD

  ASST Grande Ospedale Metropolitano Niguarda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Cascio Rizzo, MD

CONTACT

+390264442348; angelo.casciorizzo@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 23, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

IT (1)