Contrast Free MRI for Imaging Vascular Calcification in Diabetic Lower Extremity

无对比 MRI 对糖尿病下肢血管钙化的成像

• 批准号: 9978782
• 负责人: JIE ZHENG
• 金额: $ 7.87万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-16 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9978782
• 关键词: 3D Print; Address; Angiography; Arterial Occlusive Diseases; Arteries; Blood Vessels; Chronic; Clinical; Clinical Trials; Contrast Media; Decision Making; Detection; Development; Diabetes Mellitus; Diagnosis; Diffuse; Digital Subtraction Angiography; Disease; Distal; Electrocardiogram; Foundations; Gadolinium; Goals; Image; Individual; Intervention; Ischemia; Kidney Failure; Leg; Limb Salvage; Limb structure; Lower Extremity; Magnetic Resonance Angiography; Magnetic Resonance Imaging; Measurement; Measures; Methods; Morphologic artifacts; Obesity; Overweight; Patients; Peripheral arterial disease; Phase; Physicians; Predisposition; Process; Radiation; Radiation exposure; Risk Factors; Schedule; Sensitivity and Specificity; Signal Transduction; Stenosis; Techniques; Therapeutic; Tissues; Validation; Vascular calcification; X-Ray Computed Tomography; accurate diagnosis; calcification; clinical diagnostics; cohort; contrast enhanced; diabetic; effective therapy; foot; heart function; high risk; imaging capabilities; imaging modality; imaging study; infection risk; preservation; tool; treatment planning; wound

Diabetes is an important independent risk factor for peripheral arterial disease (PAD) and patients with both PAD and diabetes are more likely to have wound formation, infection, and higher risk of limb loss. A hallmark of PAD in the setting of diabetes, is the accumulation of densely calcified, recalcitrant, occlusive disease of the tibial and pedal arteries. However, it is difficult to non-invasively assess patency of tibial and pedal outflow arteries accurately in the lower extremities of the patients with diabetes, due to multi-segment, diffuse, and calcified plaques. In addition, the contrast media used in current clinical diagnostic tools, such as digital subtraction angiography (DSA), computerized tomographic angiography (CTA), or contrast-enhanced magnetic resonance angiography, are contraindicated to patients with diabetes who have renal insufficiency. The contrast free magnetic resonance angiography (CF-MRA) becomes a favorable imaging method in these patients. Current CF-MRA techniques demonstrated good sensitivity and specificity for the detection of arterial stenosis in lower extremities, but relies on the electrocardiography (ECG) triggering. Irregular ECG signals in patients with diabetes who are more likely to be overweight and/or obese results in suboptimal or useless angiographic findings. More importantly, current CF-MRA techniques have no robust methods to assess the extent of arterial wall calcification. The objective of this study is to develop and validate a new CF-MRA technique, without using any ECG signal, to assess both arterial stenosis and calcification. Two specific aims will be addressed. In Specific Aim 1, a new CF-MRA technique for quantitative measurements of arterial outflow vessel stenosis and calcification will be developed and validated in a 3D printed calcified vascular phantom. In Specific Aim 2, sensitivity and specificity of vascular calcification and stenosis detection will be determined in the lower extremities of 25 patients with symptomatic PAD and diabetes using the new CF-MRA technique, in comparison with CTA and DSA, respectively. It is hypothesized that the extent of calcification and stenosis degree measured by the new CF-MRA will be strongly correlated with the actual size of calcification and stenosis in the phantom (r > 0.9). High sensitivity and specificity (> 90%) will be achieved for the detection of calcification and stenosis with the new CF-MRA. The completion of this study will build a foundation to comprehensively assess the vasculature in the lower extremities of patients with PAD and diabetes, which is essential to effective treatment plans for revascularization and limb salvage.

糖尿病是外周动脉疾病（PAD）的重要独立危险因素， 同时患有PAD和糖尿病的患者更有可能有伤口形成、感染， 截肢的风险更高。PAD在糖尿病背景下的一个标志是高密度脂蛋白的积聚， 胫骨和足动脉的钙化、闭塞性疾病。但很难 准确无创评估下肢胫骨和足流出动脉的通畅性 糖尿病患者的四肢，由于多段，弥漫性和钙化斑块。在 此外，目前临床诊断工具中使用的造影剂，例如数字减影， 血管造影（DSA）、计算机断层扫描血管造影（CTA）或对比增强 磁共振血管造影，禁忌糖尿病患者谁肾 不足。 无对比剂磁共振血管造影（CF-MRA）是一种较好的 这些患者的影像学检查。目前的CF-MRA技术表现出良好的灵敏度 和下肢动脉狭窄检测的特异性，但依赖于 心电图（ECG）触发。糖尿病患者的不规则ECG信号 更有可能超重和/或肥胖的人导致次优或无用的血管造影结果。 更重要的是，目前的CF-MRA技术没有可靠的方法来评估 动脉壁钙化本研究的目的是开发和验证新的CF-MRA 技术，而不使用任何ECG信号，以评估动脉狭窄和钙化。 将讨论两个具体目标。在特定目标1中，一种新的CF-MRA技术， 将开发动脉流出道血管狭窄和钙化的定量测量 并在3D打印的钙化血管体模中验证。在具体目标2中，灵敏度和 血管钙化和狭窄检测的特异性将在较低的 25例有症状的PAD和糖尿病患者的四肢使用新的CF-MRA技术， 分别与CTA和DSA比较。据推测，钙化的程度 新的CF-MRA测量的狭窄程度与实际狭窄程度有很强的相关性， 体模中钙化和狭窄的大小（r > 0.9）。高灵敏度和特异性（> 90%） 新的CF-MRA将实现对钙化和狭窄的检测。的 这项研究的完成将为全面评估血管系统奠定基础。 PAD和糖尿病患者的下肢，这对于有效的治疗计划至关重要 进行血运重建和保肢手术