Innovative imaging techniques for assessing carotid atherosclerosis
Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control
This study tests new imaging methods to see if they can help identify dangerous plaque in the arteries of people with carotid stenosis, particularly to tell the difference between those who have had a stroke and those who haven't.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bron) |
| Trial ID | NCT02748941 on ClinicalTrials.gov |
What this trial studies
This study investigates new imaging biomarkers to evaluate carotid atherosclerosis, focusing on the vulnerability of atherosclerotic plaques. It aims to improve the understanding of plaque composition and its relationship to stroke risk by utilizing advanced imaging techniques such as High Resolution MRI and ultrasound examinations. The study includes patients with significant carotid stenosis and aims to differentiate between those who have experienced a stroke and those who have not, thereby enhancing risk assessment and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals with carotid stenosis of 50% or greater who have experienced a recent stroke or transient ischemic attack.
Not a fit: Patients with a modified Rankin scale score greater than 3 or those with serious co-morbid diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk stratification and management of patients with carotid stenosis, potentially reducing the incidence of strokes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for assessing plaque vulnerability, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Carotid stenosis ≥ 50% NASCET * Case: ipsilateral carotid stenosis stroke, certified by MRI or CT in the preceding month, with no others causes of stroke * Control: no clinical sign or MRI hint for a recent stroke * Signed informed consent form * Patient affiliated to a social security system or equivalent Exclusion Criteria: * Modified Rankin scale \> 3 * Homolateral stroke or TIA \> 1 month * Medical history of homolateral carotid surgery, cervical radiation, carotid occlusive, homolateral intracranial stenosis, risk of developing arterial thromboembolic events * Renal failure (creatinine clearance \< 50 ml/min) * Contraindication to ultrasound (sonovue) * Contraindication to MRI and its contrast media (Gadolinium) * Inability to sign informed consent * Inability to undergo any of the technics (claustrophobia…) * Serious co-morbid disease, dementia * Neurological disease with no carotid disease * Risk of pregnancy or pregnancy or breastfeeding * Adult under reinforced guardianship or legal guardian * Patient not understanding French
Where this trial is running
Bron
- Hospices Civils de Lyon - Service de radiologie — Bron, France (Recruiting)
Study contacts
- Study coordinator: Philippe DOUEK, MD
- Email: philippe.douek@chu-lyon.fr
- Phone: (0)472357233
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.