MECHANISMS OF DVT VEIN WALL REMODELING

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 深静脉血栓症(DVT)每年影响近100万人。DVT有时很难诊断，并可能与许多长期并发症有关，如静脉炎后综合征。准确的诊断和更好地预测患者发生静脉炎后综合征的风险的方法可能有助于降低与这种疾病相关的发病率。这项研究的目标人群将是18岁以上的患者，首次诊断为只有一条腿的急性DVT(深静脉血栓)。在双功超声确认急性DVT后，血管诊断科将确定潜在的研究对象。约150名患者将被招募参加这项研究。 这项研究将是两个项目的结合。 1.DVT-PI后的静脉壁重塑：Peter Henke博士。 2.微粒：预测深静脉血栓形成的新标记物-PI：Thomas Wakefield博士。这项研究目前获得了IRB的批准(HUM 2460)。HUM 2460的招聘还没有开始。HUM 2460的一个分支具有与Peter Henke博士的研究所需的相同的纳入标准。(另一组：临床症状，但双功超声阴性，将在HUM 2460的IRB修订版中解决。) 调查人员的意图是，由于两项研究都涉及相似的患者群体和程序(血液分析)，因此研究程序和两个项目的同意书应结合起来。 本研究将对深静脉血栓形成的两个不同方面进行研究。 研究的一部分将检查 1.静脉壁对深静脉血栓的反应 2.静脉壁改变与特定血液标志物的相关性。 这些信息将被用来评估特定的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以用于预测患者患上静脉炎后综合征的风险。 (这部分将在剩余的应用中称为静脉壁重塑-DVT) 研究的第二部分将检查血液样本中的生物标记物(包括促凝血微粒、可溶性P-选择素和其他标记物)，以确定一组标记物是否可以用于DVT的诊断和随后的临床决策。目前还没有可以用来单独诊断DVT的血液测试，特别是在超声波不可用的情况下。研究的这一部分在研究方案HUM2460中阐述，在剩余的应用中将被称为微粒子研究-DVT。 为了完成这项研究，受试者将接受抽血、腿部双功能超声波和患者问卷调查。研究协调员将继续负责获取知情同意，跟踪患者，并确保所有与研究相关的程序都按照这两个方案进行。

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.'