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Cardiac Imaging to Predict Embolic Stroke

N/A
Recruiting
Led By Nassir Marrouche, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of atrial fibrillation
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)
Must not have
Estimated glomerular filtration rate (eGFR) cutoff in patients with Chronic kidney disease (CKD) where gadolinium cannot be used equals an eGFR <30 ml/min
History of atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1
Awards & highlights

Summary

This trial shows that people who have left atrial or left atrial appendage pathology are at a higher risk for embolic strokes, even if they don't have atrial fibrillation. This could help doctors identify people who are at a higher risk for strokes and help prevent them in the future.

Who is the study for?
This trial is for adults over 18 without atrial fibrillation but with a high stroke risk score (CHA2DS2VASC ≥3), type II diabetes, or history of heart failure/TIA/stroke from unknown causes. It excludes those who've had recent strokes, are allergic to MRI contrast agents, have certain implants, severe kidney disease, weigh over 300 lbs, or are pregnant/breastfeeding.
What is being tested?
The study tests if advanced cardiac and brain MRI imaging can predict the risk of embolic strokes in people without atrial fibrillation by identifying specific heart abnormalities that could lead to such strokes.
What are the potential side effects?
MRI procedures are generally safe but may include discomfort from lying still during the scan. Gadolinium contrast used in MRIs can cause allergic reactions or issues in patients with severe kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had atrial fibrillation.
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I have a history of heart failure or stroke with no clear cause.
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I have been diagnosed with type II diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low, with an eGFR under 30 ml/min.
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I have a history of irregular heartbeats.
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I am able to understand and consent to my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The presence of covert embolic cerebral infarcts
Secondary study objectives
Number of counts of embolic symptomatic infracts
Number of counts of lacunar covert infracts
Number of counts of lacunar symptomatic infracts

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient armExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
119 Previous Clinical Trials
238,440 Total Patients Enrolled
3 Trials studying Stroke
8,881 Patients Enrolled for Stroke
Nassir Marrouche, MDPrincipal InvestigatorTulane School of Medicine
6 Previous Clinical Trials
948 Total Patients Enrolled

Media Library

Stroke Clinical Trial 2023: Cardiac and Brain MRI Highlights & Side Effects. Trial Name: NCT04769310 — N/A
~8 spots leftby Jan 2025