Clinical Trial for Evaluation of Vermillion's Blood Test to Predict the Probability of Peripheral Artery Disease

NCT01336426 | Completed DMC

• 1 other identifier: PAD-001
• Study Type: observational
• Target: 1,033
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; PAD

Outcome Measures

Primary Outcomes (1)

• PAD1 will identify individuals with a higher risk of PAD.

  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

Secondary Outcomes (1)

• To demonstrate that PAD1 has predictive value for PAD when used as a combination result.

  1 month

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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).

Sponsors & Collaborators

• Vermillion, Inc.: lead

Study Sites (10)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Lovelace Scientific Research

Albuquerque, New Mexico, 87108, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Omega Clinical Research

Warwick, Rhode Island, 02886, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

National Clinical Research, Inc.

Richmond, Virginia, 23294, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma and Frozen Red Blood Cells

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Eric T Fung, MD. PhD.

  Vermillion, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 15, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (10)