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Clinical Trial for Evaluation of Vermillion's Blood Test to Predict the Probability of Peripheral Artery Disease (PAD-001)

2013年12月16日更新者：Vermillion, Inc.

Purpose

This study is to verify and validate PAD1 as a qualitative serum test which will combine the results of multiple assays into a single numeric result, to be determined by evaluation of the study data.

PAD1 is an automated software device (PADCalc) that incorporates specific and multiple biomarker values found in human blood, and generates a score (PAD1 score) using a fixed formula implemented within the PADCalc software. The PAD1 score is a result with a high or low probability of PAD.

PAD1 will be submitted to FDA as a 510(k) for in vitro diagnostic use in conjunction with clinical assessment, based on factors such as age, diabetes, smoking, and vascular laboratory tests (including the ABI), as an aid towards further evaluation of patients who meet the enrollment eligilbility criteria.

Eligibility It is indicated for women and men considered at risk for PAD who meet the following criteria: a history of smoking and/or diabetes and are age 50 years or older, or 70 years of age or older. PAD1 is an aid to further assess the likelihood of the presence of PAD when used in conjunction with clinical assessment and vascular laboratory tests.

研究概览

地位

完全的

条件

外周动脉疾病

详细说明

Peripheral artery disease (PAD) affects 8 to 12 million individuals in the United States and is also prevalent in Europe and Asia. A regional pilot study of community screening for PAD demonstrated that patient awareness of a PAD diagnosis was low, and was associated with atherosclerosis risk factors, antiplatelet therapy, and claudication treatment intensity. PAD has not emerged as a focus of public health efforts to improve quality of life, nor to decrease the associated cardiovascular ischemic risk. Smoking, diabetes, and age are the strongest risk factors for PAD. Smokers have a 2 to 6-fold increased likelihood of having PAD, and the risk of PAD increases in a dose-dependent manner with the duration and amount of smoking. Diabetes confers a 2 to 4-fold increased risk of having PAD. The prevalence of PAD increases as a function of age. Criqui et al showed that the prevalence of PAD in individuals under 60 years of age was about 2.5%, whereas the prevalence increased to over 20% in individuals over 75 years of age.

A study in smokers and diabetics 50 years of age or older, and in all those 70 years of age or older, identified in an outpatient, primary care clinic setting has shown that the prevalence is 29%. About half of the cases found were newly-identified PAD patients. Further, while 83% of those with a prior diagnosis of PAD were aware of their condition, only 49% of the primary-care physicians were aware that their patients had a diagnosis of PAD. Another study examined internal medicine physicians' approaches to PAD and found that only 37% reported taking histories for claudication, and only 26% evaluated the foot for ulcers.

PAD is as prevalent in women as in men. When symptomatic, PAD causes limb discomfort, tiredness, heaviness, cramping, or pain brought on by exertion and relieved by rest (i.e., intermittent claudication) and reduces functional capacity and quality of life. Classic claudication is only noted by 10-30% of patients and atypical leg discomfort occurs in 20-40%. Up to 50% of patients are asymptomatic. PAD1 is an in vitro diagnostic that provides a PAD1 score derived from multiple biomarkers in human plasma, serum, or whole blood, which predicts a low or high probability of the presence of PAD in patients at risk for PAD. A positive PAD1 score(above the cutoff), indicating a higher risk for PAD than expected in the general population, would then guide the physician to more aggressively determine the presence of PAD.

The preliminary studies have shown an association of four proposed biomarkers with ABI, and have demonstrated the construction of a PAD risk algorithm. This study is powered to test each of the four biomarkers and their interactions and develop the PAD1 risk score in the intended use population.

研究类型

观察性的

注册 (实际的)

1033

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Alabama
  - Mobile、Alabama、美国、36608
    - Coastal Clinical Research
- California
  - Santa Ana、California、美国、92705
    - Apex Research Institute
  - Santa Rosa、California、美国、95405
    - Radiant Research
- Florida
  - Clearwater、Florida、美国、33761
    - Tampa Bay Medical Research, Inc.
- Missouri
  - Kansas City、Missouri、美国、64114
    - Center for Pharmaceutical Research
- New Mexico
  - Albuquerque、New Mexico、美国、87108
    - Lovelace Scientific Research
- Ohio
  - Columbus、Ohio、美国、43212
    - Radiant Research
- Rhode Island
  - Warwick、Rhode Island、美国、02886
    - Omega Clinical Research
- Texas
  - San Antonio、Texas、美国、78229
    - Clinical Trials of Texas, Inc.
- Virginia
  - Richmond、Virginia、美国、23294
    - National Clinical Research, Inc.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Subjects that meet the inclusion/exclusion criteria from 10 primary care sites.

描述

Inclusion Criteria:

Subject is one or more of the following:

≥50 years old and subject-reported current or former history (<10 years) of smoking for a minimum of 10 pack years.
≥50 years old and history of type 2 diabetes (meeting American Diabetes Association criteria) as documented in the medical record, or use of diabetes medications or diabetes-specific diet.
≥70 years old. 2. Subject provides written informed consent to participate in this study. 3. Subject agrees to de-identified biorepository storage of own processed blood sample for future testing.

Exclusion Criteria:

Significant hepatic or renal insufficiency, including either of the following:
- Renal insufficiency or renal failure within the past 6 months, or creatinine >2.5 mg/dL within the past 6 months (if results available), or currently on dialysis.
- Severe liver disease or any chronic hepatitis within the past 6 months, or AST and ALT >3xULN (upper limit of normal), or bilirubin >2xULN within the past 6 months (if results available).
Active viral or bacterial infection or subject is currently taking an antibiotic or antiviral agent.
Active inflammatory condition requiring treatment with systemic steroids or immune modulating therapy within the past 6 months.
Active malignancy that requires active anti-neoplastic therapy (stable basal cell skin cancer is allowed; cancer being treated solely with hormonal therapy is allowed).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：仅案例
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
PAD1 will identify individuals with a higher risk of PAD. 大体时间：1 month	PAD1 will identify individuals with a higher risk of PAD in an at-risk population of individuals 70 years of age or older, or smokers and/or diabetics 50 years of age or older.	1 month

次要结果测量

结果测量	措施说明	大体时间
To demonstrate that PAD1 has predictive value for PAD when used as a combination result. 大体时间：1 month	To demonstrate that PAD1 has predictive value for PAD in combination with: The Framingham Risk Score The 5-Symptom Questionnaire for prediction of PAD (5-Q Sx)	1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vermillion, Inc.

调查人员

研究主任：Eric T Fung, MD. PhD.、Vermillion, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2011年4月6日

首先提交符合 QC 标准的

2011年4月14日

首次发布 (估计)

2011年4月15日

研究记录更新

最后更新发布 (估计)

2013年12月17日

上次提交的符合 QC 标准的更新

2013年12月16日

最后验证

2013年12月1日