Peripheral Artery DiseasePAD-001NCT01336426
Clinical Trial for Evaluation of Vermillion's Blood Test to Predict the Probability of Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by Vermillion, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 1,033 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that meet the inclusion/exclusion criteria from 10 primary care sites.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lovelace Scientific Research
Albuquerque, New Mexico, 87108
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Radiant Research
Columbus, Ohio, 43212
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Coastal Clinical Research
Mobile, Alabama, 36608
National Clinical Research, Inc.
Richmond, Virginia, 23294
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Apex Research Institute
Santa Ana, California, 92705
Radiant Research
Santa Rosa, California, 95405
Omega Clinical Research
Warwick, Rhode Island, 02886
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, PAD
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
To demonstrate that PAD1 has predictive value for PAD when used as a combination result.
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vermillion, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric T Fung, MD. PhD., Study director, Vermillion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336426
- Sponsor's protocol ID
- PAD-001
- Acronym
- PAD-001
- Status last verified
- Dec 2013
- First submitted
- 6 Apr 2011
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Evaluation of Vermillion's Blood Test to Predict the Probability of Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT01336426
- Acronym / sponsor ID
- PAD-001 / PAD-001
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, PAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- Vermillion, Inc.University, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that meet the inclusion/exclusion criteria from 10 primary care sites.
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (6 listed)
- Significant hepatic or renal insufficiency, including either of the following:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PAD1 will identify individuals with a higher risk of PAD.
Time frame: 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 secondary outcome
To demonstrate that PAD1 has predictive value for PAD when used as a combination result.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric T Fung, MD. PhD. study director
Vermillion, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Vermillion, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAD1 will identify individuals with a higher risk of PAD. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.