Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Atrial Fibrillation
Stroke
Stroke, Cardiovascular
Stroke Ischemic
Strokes Thrombotic
Vascular Cognitive Impairment

Type

Interventional

Phase

Not Applicable

Design

Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 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. CMR protocol will include Cine MRI, contrast-enhanced (CE) MR Angiography (MRA), time-resolved 2D phase-contrast (PC) MRI, and 3D late gadolinium enhancement (LGE) involving gadolinium injection. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. 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).Masking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age: Between 18 years and 120 years
Gender: Both males and females

Description

The investigators propose a cross-sectional cohort study, where individuals with no history of AF and with a Congestive heart failure, Hypertension, Age ? 75 years, Diabetes mellitus, Stroke or transient ischemic attack (TIA), Vascular disease, Age 65 to 74 years, Sex category score (CHA2DS2VASC) ?3, type II diabetes, congestive heart failure or a history of stroke/TIA will be included. Data on demographics, personal health habits, medications, and medical history will be obtained by interviewing participants and reviewing the electronic medical records. All participants will undergo a Cardiac Magnetic Resonance imaging (CMR) to assess for markers of LA and LAA pathology. Markers of LA and LAA pathology that will be studied include: LA fibrosis level, LA functional parameters, LA shape characteristics, and LAA characteristics (including morphology, orifice area and flow velocity). Additionally, all participants will undergo a brain Magnetic Resonance Imaging (MRI) at the same visit to assess for the presence of embolic-appearing brain infarcts, regardless of previous stroke-related symptoms. 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.

Tracking Information

NCT #: NCT04769310
Collaborators: Not Provided
Investigators: Principal Investigator: Nassir Marrouche, MD Tulane School of Medicine