Detecting vascular dysfunction using advanced imaging techniques
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
This study is testing a new imaging technique to see if it can help find soft plaques in the carotid artery that might cause silent strokes in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04632485 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the use of Lagrangian carotid strain imaging (LCSI) to identify soft plaques in the carotid artery that may be prone to rupture, potentially leading to silent strokes. The study will involve healthy adult volunteers who will undergo ultrasound imaging and MRI to evaluate age-related strain variations in carotid plaques. By establishing typical and atypical strain indices, the study seeks to validate ultrasound as a real-time screening tool for vascular health. The hypothesis is that softer plaques with higher strain indices are more likely to rupture than stiffer plaques.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older who can provide informed consent and are willing to participate in the study over five years.
Not a fit: Patients with a history of significant vascular disease, stroke, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of vascular dysfunction, potentially preventing strokes.
How similar studies have performed: While the approach of using strain imaging is innovative, similar studies have shown promise in identifying vascular health indicators, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Aim 1 (Ultrasound (US) only): * Adults at least 18 years * Are able to provide written informed consent on their own behalf Aim 2 (US and MRI): * Participation in the US study (Aim 1) * Determined by presence of hypoechogenic or echolucent lipid-rich soft plaque during initial ultrasound imaging session * Adults willing to participate over 5 years Exclusion Criteria: Aim 1 (US only) * Women that are currently pregnant * Inability to cooperate with the ultrasound study, in particular those unable to sit without gross movement for the duration the ultrasound study (estimated at 60-90 minutes) * Open wounds or sores in the anterior neck * History of cancer treatment, vascular disease, cardiac disease, stroke or TIA * History of medications that affect vascular wall and plaque * History of statin medications\* * History of hypertension medications\* * History of anticoagulation, blood thinners * These criteria will not be exclusionary for the cohort that is greater than 70 years of age. Aim 2 (US and MRI): * Women that are currently pregnant * Inability to cooperate with the ultrasound study, in particular those unable to sit without gross movement for the duration the ultrasound study (estimated at 60-90 minutes) * Patients that require intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for research imaging will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication; * The informed consent process is conducted prior to the self-administration of this medication; and, * The participant comes to the research visit with a driver * Contraindications to MR * Unable to lie in the MRI scanner for 45-60 minutes * Patients with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
Where this trial is running
Madison, Wisconsin
- Department of Medical Physics, University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Tomy Varghese, PhD — University of Wisconsin, Madison
- Study coordinator: Study Coordinator
- Email: Radstudy@uwhealth.org
- Phone: 608-263-7421
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.