Atherosclerosis Clinical Trial
Official title:
Ultrasonic Mapping of Carotid Plaque Composition
Pilot prospective two group observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.
Stroke is a major cause of morbidity and mortality among patients with cardiovascular disease
and the major cause of long-term disability in the United States. Current imaging modalities
can determine the severity of luminal stenosis resulting from plaque, as in the carotid
arteries. However, cerebrovascular accidents (CVAs) are often associated with the rupture of
unstable plaques located in regions with a non-significant degree of luminal stenosis. Thus
up to 50% of high-risk atherosclerotic plaques may go undetected and untreated. Plaque
composition is an additional and perhaps, more important risk factor for CVA rather than
stenosis severity alone. Accurate identification of these high-risk, rupture-prone plaques
may potentially prevent CVAs in a significant number of patients.
The data collected during this study (ultrasonic backscatter and histologically processed
carotid plaque) will provide the basis for a novel algorithm to add plaque composition
information to the plaque size and location information that is currently provided by
standard ultrasound imaging. The input parameters for the algorithm are derived from two
types of non-invasive ultrasound data: spectral parameters and acoustic radiation force
impulse (ARFI) data. Spectral parameters are extracted from the frequency content of the
backscattered diagnostic ultrasound signals. These are the same signals currently used for
imaging, however, imaging relies solely on the strength of the signal to form the image and
ignores the spectral information. Thus spectral analysis is an approach to use the
information which is sensitive to the number and nature of the scatterers. In contrast ARFI
techniques provide information on the stiffness of the tissue. ARFI is based on using a
ultrasonic push pulse to slightly move the tissue (displacement on the order of microns) and
an image of the relative displacements of the tissue (ARFI image) is created. The ARFI
derived data and the spectral parameters will be combined with clinically available measures
currently used for diagnosis of carotid stenosis to form the input parameters for the
algorithm. In order to train and test the algorithm the plaque removed during surgery will be
collected and the histology slides prepared from these plaques. This histology review
provides the 'gold' standard for training and testing the algorithm. The majority of these
matched sets (67%) will be used for training the algorithm. While the remainder (33%) will
provide a test of the accuracy of the algorithm for these types of matched data. The
sensitivity and specificity for each tissue type defined during the histology review will be
reported.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
Completed |
NCT02377310 -
Pd/Pa vs iFRâ„¢ in an Unselected Population Referred for Invasive Angiography
|
N/A | |
Not yet recruiting |
NCT01923012 -
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
|
Phase 2 |