Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study
NCT ID: NCT04769310
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2021-04-26
2026-01-31
Brief Summary
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Detailed Description
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The investigators will analyze the association between each cardiac imaging feature and the prevalence of embolic-appearing strokes on brain MRI to determine whether patients with higher LA and LAA remodeled features are more likely to have embolic-appearing brain infarcts on MRI. The LA and LAA pathology imaging features with the strongest statistical association will be used to develop an imaging predictive score capable of identifying patients with the highest risk of embolic stroke.
All brain and cardiac imaging data will be assessed by experienced operators at Tulane Medical Center facilities. Operators analyzing CMR will be blinded to brain MRI results, and operators assessing brain MRI will be blinded to CMR results. The study will include a single center study at Tulane Medical Center and Clinics, with investigators from different medical specialties, and the proper facilities and equipment to conduct the project accurately and safely. The investigators expect a recruitment of 120 subjects over a period of 18 months from both cardiology and neurology clinics to complete the study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
Brain MRI will be used for the detection of embolic infarcts assessed on high-resolution brain MRI acquisitions. The high-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 Magnetization Prepared Rapid Acquisition Gradient Echo (MPRAGE), 3D fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI), apparent diffusion coefficient maps (ADC), and susceptibility weighted imaging (SWI).
DIAGNOSTIC
NONE
Study Groups
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Patient arm
All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA.
High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI
Cardiac and Brain MRI
A CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner will be used. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA.
High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI
Interventions
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Cardiac and Brain MRI
A CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner will be used. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA.
High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI
Eligibility Criteria
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Inclusion Criteria
* 18 Years and older
* No history of atrial fibrillation
* CHA2DS2VASC score ≥3
* History pf type II diabetes
* History of congestive heart failure or a history of transient ischemic attack (TIA)/stroke without an otherwise defined stroke etiology such as large vessel or small vessel disease
Exclusion Criteria
* Patients who had a clinically symptomatic acute stroke within the last 30-days
* Any health-related gadolinium/MRI contraindication (including previous allergic reaction to Gadolinium, pacemakers, defibrillators, other devices/implants contraindicated for MRI)
* Estimated glomerular filtration rate (eGFR) cutoff in patients with Chronic kidney disease (CKD) where gadolinium cannot be used equals an eGFR \<30 ml/min
* Weighing \> 300 lbs (as CMR image quality decreases due to increased body mass index)
* Current pregnancy or breastfeeding
* Cognitive impairment preventing the patient from giving an informed consent
18 Years
120 Years
ALL
No
Sponsors
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Tulane University
OTHER
Responsible Party
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Principal Investigators
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Nassir Marrouche, MD
Role: PRINCIPAL_INVESTIGATOR
Tulane School of Medicine
Locations
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Tulane University Medical Center
New Orleans, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Quintrele Jones, MPH
Role: primary
References
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Other Identifiers
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2020-2151
Identifier Type: -
Identifier Source: org_study_id