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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day1

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met