Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
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| ClinicalTrials.gov Identifier: NCT04632485 |
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Recruitment Status :
Recruiting
First Posted : November 17, 2020
Last Update Posted : March 3, 2022
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The purpose of this research is assess imaging and identification of soft plaque that undergoes large deformations or strain will identify plaque vulnerable to rupture which could lead to 'silent strokes'. Validation of current study results with MRI will foster use of real-time ultrasound (US) strain imaging and strain indices as a screening tool for identifying normal human participants susceptible to increased vascular aging and developing plaque prone to rupture or micro-embolization.
Current research will evaluate Lagrangian carotid strain imaging (LCSI) for prediction of vascular health on volunteers. In this study, investigators will evaluate age-related strain variations (due to plaque deposition) in the carotid artery, establishing groundwork that will help identify typical and atypical values for these indices. Investigator's hypothesis is that plaques with higher strain indices (softer plaques) are more prone to rupture than plaques with lower strain indices (stiffer) plaques, thus requiring intervention. Clinical criteria for treatment has focused primarily on the degree of stenosis. Long-term objectives are to provide non-invasive methods for screening participants at risk for vascular aging or plaque rupture in asymptomatic participants, expanding upon current criteria for risk assessments based on focal transient ischemic attack (TIA) or strokes. Variations in vessel strain have been associated with, or are precursors to, plaque deposition, vascular aging, or cerebrovascular diseases. Increased arterial strain and pressure changes have been linked to brain aging using magnetic resonance imaging (MRI) based vascular indices, and memory deficits commonly linked to Alzheimer dementia. Stiffening and thickening of the arterial walls have also been associated with cerebrovascular disease. Investigators hypothesize that strain indices as vascular biomarkers can be utilized for screening possible 'vulnerable participants' validated with MRI, with the potential ability to improve endothelial function and reverse vascular aging. Strain indices may enable differentiating study participants with vascular cognitive impairment (VCI) from other dementias. Cognitive testing is unable to make this differentiation.
| Condition or disease | Intervention/treatment |
|---|---|
| Healthy Carotid Artery Diseases | Device: Ultrasound imaging Device: Magnetic Resonance Imaging (MRI) |
| Study Type : | Observational |
| Estimated Enrollment : | 280 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging |
| Actual Study Start Date : | September 9, 2021 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Aim 1: Ultrasound Only
Approximately 280 asymptomatic participants will participate in ultrasound (US) studies and blood work.
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Device: Ultrasound imaging
Carotid artery ultrasound exam. US imaging will include complete clinical carotid ultrasound examination (B-mode, Doppler and color-flow modes), clinical strain and shear wave imaging study, backscattered and beam-steered radiofrequency (RF) data acquisition using research mode, and reference phantom RF data acquisition. |
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Aim 2: Ultrasound and MRI
A sub-group of 40 at risk volunteers determined from the clinical ultrasound scans and bloodwork from Aim 1 will be asked to participate in a longitudinal US and MRI study. Participants will be selected from a population of individuals that do not have significant atherosclerosis, but present with increased risk due to the presence of soft, lipid rich plaque that are hypoechogenic or echolucent on ultrasound B-mode images. These participants may also satisfy the current clinical guidelines of increased vessel diameter and decreased blood flow velocity with ultrasound that may result in plaque deposition for being in the at risk population. Participants will receive US, strain and shear wave imaging every 2 years after the first scan in Aim 1 and MRI Imaging in Year 1 and Year 5: separated by 4 years
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Device: Ultrasound imaging
Carotid artery ultrasound exam. US imaging will include complete clinical carotid ultrasound examination (B-mode, Doppler and color-flow modes), clinical strain and shear wave imaging study, backscattered and beam-steered radiofrequency (RF) data acquisition using research mode, and reference phantom RF data acquisition. Device: Magnetic Resonance Imaging (MRI) Head and Neck MRI exam with contrast |
- Characterization of artery wall stiffness and possible plaque by capturing B-mode, Doppler and color-flow modes of Ultrasound [ Time Frame: up to 60 minute ]Participants will receive complete clinical carotid ultrasound examination. B-mode, Doppler and color-flow modes of Ultrasound will be captured. This measure will characterize artery wall stiffness and possible plaque by using Ultrasound.
- Characterization of artery wall stiffness and possible plaque by using Ultrasound by clinical strain and shear wave imaging [ Time Frame: up to 60 minute ]Participants will receive complete clinical carotid ultrasound examination. Clinical strain and shear wave imaging will be performed. This measure will characterize artery wall stiffness and possible plaque by using Ultrasound.
- Carotid artery ultrasound examination for Aim-1 participants: backscattered and beam-steered RF data acquisition using research mode [ Time Frame: up to 60 minute ]Participants will receive complete clinical carotid ultrasound examination. Backscattered and beam-steered RF data acquisition using research mode, and reference phantom RF data acquisition will be performed. This measure will characterize artery wall stiffness and possible plaque by using Ultrasound.
- Fasting Lipid panel Analysis [ Time Frame: up to 13 hours ]For aim-1 participants, a single fasting (10-12 hours) blood sample will be collected for a fasting lipid panel
- Hemoglobin A1C test for diabetes [ Time Frame: up to 13 hours ]For aim-1 participants, a single fasting (10-12 hours) blood sample will be collected for a Hemoglobin A1C test
- High-sensitivity C-reactive protein (HS-CRP) test for inflammatory markers for Aim 1 participants [ Time Frame: up to 13 hours ]For aim-1 participants, a single fasting (10-12 hours) blood sample will be collected for High-sensitivity C-reactive protein (HS-CRP) test
- Detection of Plaques by MRI- Accuracy of MRI detection method as compared to Ultrasound and blood work [ Time Frame: up to 60 minute ]
Longitudinal Ultrasound strain and MRI study will be performed on on a sub-group of 40(aim-2) at risk participants determined from the clinical ultrasound scans and bloodwork from Aim 1. This subgroup meet the criteria for being in a higher risk group for atherosclerosis or those with softer lipid-rich plaque (hypoechogenic or lower brightness on ultrasound).
Participants will be contacted on the phone to discuss these incidental findings and to request if they would be interested in participating in follow-up MRI, US and strain. MRI results will be compared to previous Ultrasound and blood work results to test the accuracy of MRI method in detecting plaques.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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 cardiac disease, stroke or TIA
- History of statin medication
- History of hypertension medications
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 sedative medication for imaging
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632485
| Contact: Study Coordinator | 608-263-7421 | Radstudy@uwhealth.org | |
| Contact: Suzanne Hanson | 608-263-7421 | shanson@uwhealth.org |
| United States, Wisconsin | |
| Department of Medical Physics, University of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Tomy Varghese, PhD 608-265-8797 tvarghese@wisc.edu | |
| Principal Investigator: | Tomy Varghese, PhD | University of Wisconsin, Madison |
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT04632485 |
| Other Study ID Numbers: |
2020-0384 A534800 ( Other Identifier: University of Wisconsin, Madison ) SMPH/MED PHYSICS ( Other Identifier: University of Wisconsin, Madison ) 1/18/2022 ( Other Identifier: Protocol Version ) 1R01HL147866-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 17, 2020 Key Record Dates |
| Last Update Posted: | March 3, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |