Using advanced cardiac imaging to predict strokes in patients without atrial fibrillation
Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study
This study is testing if advanced heart imaging can help predict strokes in people who don't have atrial fibrillation by looking for specific signs in their hearts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT04769310 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a connection between left atrial and left atrial appendage pathology and the occurrence of embolic strokes in individuals who do not have a history of atrial fibrillation. It will involve a cross-sectional cohort of patients with specific risk factors, who will undergo cardiac magnetic resonance imaging (CMR) and brain MRI to identify potential markers of stroke risk. The study will analyze the relationship between cardiac imaging features and the presence of embolic strokes on brain MRI, potentially leading to improved stroke prevention strategies. By identifying high-risk individuals based on imaging criteria, the study seeks to inform future anticoagulation strategies for stroke prevention beyond atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a CHA2DS2VASC score of 3 or higher and a history of type II diabetes or congestive heart failure, but no history of atrial fibrillation.
Not a fit: Patients with a history of atrial fibrillation or those who have had a recent symptomatic stroke within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients at risk for embolic strokes, allowing for targeted prevention strategies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using imaging to assess stroke risk, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients * 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: * History of atrial fibrillation * 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
Where this trial is running
New Orleans, Louisiana
- Tulane University Medical Center — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Nassir Marrouche, MD — Tulane School of Medicine
- Study coordinator: Quintrele Jones, MPH
- Email: qjones1@tulane.edu
- Phone: 504-988-3063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.