Actively Recruiting
Cardiac Assessment for Thrombus Detection Using MRI and CT in Embolic Stroke of Undetermined Source with Left Ventricular Disease
Led by Niguarda Hospital · Updated on 2025-12-23
125
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating advanced cardiac imaging techniques to improve the detection of blood clots in the hearts of patients who have had an embolic stroke of undetermined source (ESUS) with left ventricular disease (LVD). LVD includes conditions where the heart's left ventricle has reduced function or structural abnormalities, which may cause intermittent clot formation that is hard to detect with standard echocardiography. The study aims to determine whether cardiac MRI (CMRI) and cardiac CT (CCT) provide additional useful information beyond standard imaging for better risk assessment and prevention of stroke recurrence. The study is observational and will be conducted over three years, including a two-year recruitment phase and one year of follow-up. It involves three phases: initially screening all ESUS patients with LVD using transthoracic echocardiography (TTE), then applying advanced cardiac imaging (CMRI and/or CCT) for those without detected clots on TTE within 15 days of the stroke, and finally a 24-month follow-up to monitor vascular events, recurrent strokes, bleeding, heart rhythm issues, mortality, and treatment changes. Participants will undergo imaging assessments including TTE and advanced cardiac imaging. Researchers will collect data on clot prevalence, cardiac and clinical characteristics, and how imaging results influence treatment decisions. Outcomes such as stroke recurrence, embolism, coronary events, bleeding events, and mortality will be tracked for two years. The main measure is the presence of left ventricular thrombi detected by advanced imaging within 15 days after stroke onset. This study aims to provide real-world evidence on the value of advanced cardiac imaging in secondary stroke prevention.
CONDITIONS
Brief 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 of 4 or less
- Diagnosis of acute ischemic stroke confirmed by CT or brain MRI
- Diagnosis of embolic stroke of undetermined source (ESUS) by standard criteria
- Stroke is not lacunar (subcortical infarction ≤1.5 cm on CT or ≤2.0 cm on diffusion-weighted MRI)
- Absence of extracranial or intracranial artery stenosis ≥50% in vessels supplying the ischemic area
- No major cardioembolic source such as atrial fibrillation, sustained atrial flutter, intracardiac thrombus detected by transthoracic echocardiography, mechanical heart valve, atrial myxoma, moderate or severe mitral stenosis, recent myocardial infarction within 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 of the following: ejection fraction 30-49%, left ventricular wall motion abnormalities not related to recent myocardial infarction, left ventricular aneurysm, enlarged left ventricle with or without spontaneous contrast, 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 authorized representative
You will not qualify if you...
- Presence of major cardioembolic sources as specified in ESUS criteria
- Thrombophilic state secondary to active cancer diagnosed within 6 months, ongoing cancer treatment, or hematologic cancer not in remission
- Ipsilateral carotid plaques with high-risk features such as thrombus, floating thrombus, or ulcerated plaque
- Patients under 60 years old with high-risk patent foramen ovale classified as probable PFO-associated stroke
- Pregnancy or puerperium
- Contraindications to MRI or CT with contrast agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days from the index stroke
Participants with embolic stroke of undetermined source and left ventricular disease undergo transthoracic echocardiography (TTE) and, if no thrombus is detected, advanced cardiac imaging such as cardiac MRI and/or CT within 15 days from the stroke event to detect intracardiac thrombi.
1 to 2 visits depending on imaging results
Duration - 24 months
Participants are followed for 24 months to monitor vascular events, recurrent strokes, bleeding events, atrial fibrillation, mortality, and any changes in therapy.
Periodic visits or assessments during follow-up
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
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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