Clinical Trial for Evaluation of Vermillion's Blood Test to Predict the Probability of Peripheral Artery Disease
Completed
Conditions studied: Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01336426
- Run by
- Vermillion, Inc.
- People needed
- 1033
- Starts
- 2011-03-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2013-12-17
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Coastal Clinical Research — Mobile, Alabama, United States
- Apex Research Institute — Santa Ana, California, United States
- Radiant Research — Santa Rosa, California, United States
- Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
- Center for Pharmaceutical Research — Kansas City, Missouri, United States
- Lovelace Scientific Research — Albuquerque, New Mexico, United States
- Radiant Research — Columbus, Ohio, United States
- Omega Clinical Research — Warwick, Rhode Island, United States
- Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
- National Clinical Research, Inc. — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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