Assessing blood vessel growth in asymptomatic carotid stenosis using ultrasound
Predictive Value of Carotid Lesion Neovascularization Detected by Contrast-enhanced Ultrasound (CEUS) in Patients With Asymptomatic Carotid Stenosis
This study is trying to see if a special ultrasound can help find tiny blood vessels in the neck arteries of people who have narrowing but no symptoms, to better understand the risk of future strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT01732523 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of neovascularization in asymptomatic carotid stenosis by utilizing contrast-enhanced ultrasound (CEUS) imaging techniques. The study aims to identify the microcirculation within the vessel wall and atherosclerotic plaques, which may indicate plaque vulnerability. Participants will receive a CEUS examination after the injection of ultrasound contrast agents to evaluate the presence of vasa vasorum associated with carotid stenosis. The findings could enhance understanding of plaque stability and the risk of future cerebrovascular events.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic adults over 18 years with at least 30% carotid stenosis as determined by standard ultrasound.
Not a fit: Patients with a history of carotid surgery, severe heart failure, recent myocardial infarction, or significant pulmonary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients with carotid stenosis, potentially preventing strokes.
How similar studies have performed: While the approach of using CEUS for assessing carotid stenosis is established, the specific focus on neovascularization in asymptomatic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age \> 18 years * Asymptomatic (no history of cerebrovascular event in the corresponding vessel territory) ≥30% carotid stenosis on standard carotid ultrasound Exclusion Criteria: * History of previous carotid endarterectomy or carotid stenting. * Heart failure (HYHA III or IV) * Myocardial infarction (\<7d) * Severe pulmonal-arterial hypertension (pulmonal arterial pressure \>90mmHg) based on clinical information (history of pulmonal arterial pressure, dyspnea on exertion New York Heart Association (NYHA) III and NYHA IV) * pregnancy (pregnancy test in patients of childbearing age: \<50 years and/or less than 2 years after menopause) * Follow-up is not considered feasible
Where this trial is running
Basel
- Unversity Hospital Basel, Angiology — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Daniel Staub, MD — University Hospital Basle, Angiology
- Study coordinator: Daniel Staub, MD
- Email: daniel.staub@usb.ch
- Phone: +41612655154
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.