MECHANISMS OF DVT VEIN WALL REMODELING

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 DVT（深静脉血栓形成）每年影响近一百万人。DVT有时很难诊断，并且可能与许多长期并发症有关，如静脉后综合征。准确的诊断和方法，以更好地预测病人的风险发展静脉后综合征可能有助于减少发病率往往与这种疾病。本研究的目标人群为18岁以上的患者，仅在一条腿首次诊断为急性DVT（深静脉血栓形成）。多普勒超声确认急性DVT后，将在血管诊断室确定潜在的研究受试者。本研究将招募约150例患者。 这项研究将是两个项目的结合。 1. DVT后的静脉壁重塑- PI：Peter Henke博士。 2.微粒：预测深静脉血栓形成的新标志物-PI：托马斯韦克菲尔德博士。本研究目前已获得IRB批准（HUM 2460）。第2460章还没开始HUM 2460的一个组具有与Peter Henke博士研究所需相同的入选标准。(The其他组：有临床症状但多普勒超声检查结果为阴性，将在IRB修订版HUM 2460中进行说明。） 研究者的目的是，由于两项研究涉及相似的患者人群和程序（血液分析），因此将两个项目的研究程序和知情同意书合并。 本研究将对DVT的两个不同方面进行检查。 这项研究的一部分将研究 1.静脉壁对深静脉血栓的反应 2.静脉壁变化与特定血液标志物之间的相关性。 这些信息将用于评估特定血液标志物与静脉壁损伤之间是否存在相关性，以及这些变化是否可用于预测患者发生静脉炎后综合征的风险。 (this部分将被称为静脉壁重塑-DVT（在申请的其余部分中） 研究的第二部分将检查血液样本的生物标志物（包括促凝血微粒，可溶性P-选择素和其他标志物），以确定一组标志物是否可用于DVT的诊断和随后的临床决策。目前还没有血液检查可以单独用于诊断DVT，特别是当超声不可用时。研究的这一部分在研究HUM 2460的方案中进行了说明，在其余申请中将被称为微粒研究-DVT。 为了完成本研究，受试者将接受抽血、腿部多普勒超声检查和患者问卷调查。研究协调员将负责获得知情同意书、跟踪患者，并确保所有研究相关程序均按照两项方案进行。'

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DVT (Deep Vein Thrombosis) affects close to one million people annually. DVT's are sometimes difficult to diagnosis and can be associated with many long-term complications such as post-phlebetic syndrome. Accurate diagnosis and methods to better predict a patient's risk of developing post-phlebetic syndrome may help reduce the morbidities often associated with this disease. The target population for this study will be patients over 18 years of age, presenting with a first time diagnosis of acute DVT (Deep Vein Thrombosis) in one leg only. Potential study subjects will be identified in the Vascular Diagnostic Unit after a duplex ultrasound has confirmed an acute DVT. Approximately 150 patients will be recruited for the study. This study will be a combination of two projects. 1. Vein Wall remodeling after DVT- PI: Dr. Peter Henke. 2. Microparticles:Novel Markers to predict Deep Venous Thrombosis-PI: Dr. Thomas Wakefield. This study currently is IRB approved (HUM 2460). Recruitment for HUM 2460 has not yet begun. One arm of HUM 2460 has the same inclusion criteria as needed for Dr. Peter Henke's study. (The other arm: clinically symptomatic but negative by duplex ultrasound will be addressed in an IRB revision of HUM 2460.) It is the intent of the investigators that since both studies involve similar patient population and procedures (blood analysis) that study procedures and consent forms for both projects be combined. Two different aspects of DVT will be examined in this study. One portion of the study will examine 1. The way the vein wall responds to a DVT 2. The correlation between vein wall changes and particular blood markers. This information will be used to evaluate if there is a correlation between particular blood markers and damage to the vein wall, and whether these changes may be used to predict a patient's risk of developing post-phlebitic syndrome. (this portion will be referred to as Vein Wall Remodeling -DVT in remainder of application) The second portion of the study will examine blood samples for biomarkers( including procoagulant microparticles, soluble P-selectin and other markers) to determine if a panel of markers could be utilized in the diagnosis of DVT and subsequent clinical decision making. Currently there are no blood tests that can be used to diagnose DVT in isolation, especially when ultrasound is not available. This portion of the study is addressed in the protocol of study HUM2460 and will be referred to as microparticle study-DVT in remainder of application. In order to accomplish this study subjects will undergo blood draws, duplex ultrasound of the legs and patient questionaires. Study coordinators will maintain responsibility for obtaining informed consent, tracking patients, and assuring all study related procedures are performed in accordance with both protocols.'