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临床试验/NCT02476396
NCT02476396已完成不适用

Structural Stability of Carotid Plaque and Symptomatology

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2015年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Change in Ultrasound Strain Measurements (Gray Scale Median Value) on Carotid Plaques

研究概览

简要总结

The purpose of the research is to understand structural plaque abnormalities that make a carotid plaque unstable and brake off (embolize) which would help to predict and treat individuals who are likely to suffer not only classic episodic major strokes but also cognitive impairment.

详细描述

This study examines the relationship between the structural stability of carotid atherosclerotic plaque forming at the bifurcation of the common internal/external carotids and the ability of such lesions to cause disease. The theory behind this work is the hypothesis that carotid atherosclerotic stroke presents not only as a classical episodic clinical condition, but may also involve elements of a continuous process involving large and small vessel circulations, microcirculatory changes, cellular metabolic resistance to ischemia and micro embolic events. Recent studies suggest for every recognized clinical stroke, 5 silent strokes take place.

The patient implications are enormous as imaging suggests 11 million "silent strokes" occur yearly in the US with poor understanding of the pathophysiology or cognitive consequences for our patients. Within this framework, the investigators choose to study the hypothesis that carotid artery atherosclerosis is likely to cause microemboli, as well as classic macroemboli, which may result in more subtle disturbances than those ordinarily detected by more obvious clinical events such as stroke and transient ischemia attacks.

Understanding the structural plaque abnormalities that render a carotid plaque unstable and at risk of embolization would help to predict and treat individuals who are likely to suffer not only classic episodic major strokes, but also cognitive impairment from the contribution of microemboli to this overall disease process. The investigators have previously described a non-invasive ultrasound-based measure of plaque structural stability which will be further studied in this proposal. This study will expand on previous work performed at the University of Wisconsin-Madison, and will include patients with carotid artery stenosis, both with and without classic stroke symptoms, as well as a control group of patients without known atherosclerotic disease. Current treatments for carotid artery stenosis include either carotid endarterectomy to remove plaque or carotid stenting using a expandable metal coil to prevent the artery from narrowing.

In the previous version of this protocol, the investigators have enrolled 95 -subjects (75 patient-subjects and 20 control-subjects) with no safety concerns. Findings include new understanding of the relatively of atherosclerosis and cognition as well as the basic pathophysiology of atherosclerotic large to small vessel disease.

The study will run for 5 years from IRB approval with potential to further expand it. All patient-subjects will have a baseline and 1-year follow-up, ultrasound, TCD, blood collection and cognitive study to see if endarterectomy or stenting (endovascular) affected pre-op change. Change in cognition will be compared to report studies in the normal control group. In past, carotid patients have been recruited at a greater pace. Given the complexity of these studies the investigators anticipate recruitment and complete analysis of 20 patients/year. During this time initial psychological testing will be done pre-operatively. During the final year of the study, the data analysis of the plaque ultrasounds, and histopathology and 1-year follow-up the patient received in the last year of recruitment will take place. The investigators can recruit additional patients to fill any missing data points if these results identify a subset of classically asymptomatic patients with significant carotid plaques and microemboli causing vascular cognitive decline.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Ultrasound Strain Measurements (Gray Scale Median Value) on Carotid Plaques

时间窗: baseline (pre-surgery), 1 year follow up

Ultrasound Radio frequency (RF) data will be acquired on patients, using both one-dimensional (1D) and two-dimensional (2D) wobbler and/or matrix array transducers to obtain four-dimensional (3D + time) RF data sets. The hypothesis is that plaques which have a lower gray scale median value and which during deformations of the cardiac cycles show larger stress concentrations in these regions are more vulnerable to rupture.

Change in Systolic to diastolic ratio measured by transcranial Doppler (TCD)

时间窗: baseline (pre-surgery), 1 year follow up

TCD will be utilized to acquire systolic to diastolic (S/D) ratio of blood flow in the right and left middle cerebral arteries.

Change in In-vivo velocity measured by Transcranial Doppler (TCD)

时间窗: baseline (pre-surgery), 1 year follow up

TCD will be utilized to acquire in-vivo velocity (peak systolic, mean, and end diastolic velocity information) measurements of blood flow in the right and left middle cerebral arteries.

Change in Pulsatility index measured by transcranial Doppler (TCD)

时间窗: baseline (pre-surgery), 1 year follow up

TCD will be utilized to acquire pulsatility index (PI) measurements of blood flow in the right and left middle cerebral arteries.

Change in Resistive index measured by transcranial Doppler (TCD)

时间窗: baseline (pre-surgery), 1 year follow up

TCD will be utilized to acquire resistive index (RI) measurements of blood flow in the right and left middle cerebral arteries.

Histopathologic classification of carotid atherosclerotic plaque after removal for plaque ulceration

时间窗: obtained day of surgery

Histologic classification of plaques is made using the updated classification of atherosclerotic plaques recommended by the American Heart association.

Change in Impairment Index - General Cognitive Morbidity

时间窗: baseline (pre-surgery), 1 year follow up

General cognitive morbidity will be derived by comparison of the Kaufman 4-subtest IQ and NART. The NART is brief standardized test that assesses an individual's ability to read irregular words (e.g., subtle). Performance on this test has been shown to be highly correlated with years of formal education and premorbid intellectual ability as assessed by traditional intelligence tests. Performance on NART will serve as a comparison against which to compare current IQ as determined by a brief 4-subtest version of the WAIS-R. This abbreviated IQ measure has been demonstrated to have very high correlation (r \> .95) with the complete standard WAIS-R Full Scale IQ. Comparison of predicted versus obtained IQ will provide a measure of potential cognitive decline to be used in comparison of groups at study entry.

次要结局

  • Change in Impairment Index - Number of Abnormal Test Scores(baseline (pre-surgery), 1 year follow up)
  • Change in Impairment Index - Cognitive Domain Z-scores(baseline (pre-surgery), 1 year follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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