Novel Blood Biomarker for Peripheral Arterial Disease

October 20, 2022 updated by: Mohammad Qadura, Unity Health Toronto

Artery Alert - Revolutionizing the Diagnosis of Peripheral Arterial Disease

This study focuses on validating the clinical efficacy of a novel point of care diagnostic blood test for peripheral arterial disease (PAD) within a large, heterogeneous patient population. With support from CIHR, our aim is to overcome the knowledge-to-action gaps regarding inadequate and underutilized diagnostic modalities in patients with PAD who at high risk of cardiovascular (CV) events. We propose to ascertain the diagnostic accuracy of a blood-based marker for PAD by cross-validating it with the current gold-standard.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lower extremity peripheral arterial disease (PAD) is a common presentation of atherosclerosis, affecting 256 million people globally. Despite its prevalence, approximately 50% of PAD patients are either undiagnosed, misdiagnosed, or get diagnosed late in their disease status4. Asymptomatic patients, in particular, account for these devastatingly high rates of under-diagnosis. Studies demonstrate that over 60% of PAD patients are asymptomatic, and their paucity of clinical symptoms makes diagnosis immensely difficult. Concerningly, asymptomatic PAD patients are at a similar risk of death, heart attacks and limb loss as clinically symptomatic PAD patients.

Consequently, PAD patients (both symptomatic and asymptomatic) receive delayed treatment subsequently face a higher risk of lower extremity amputation, CV events, and mortality. A possible solution to reduce the incidence of PAD induced morbidity and mortality is through early diagnosis, as studies have shown that it leads to improved survival and limb salvage rates16. However, diagnosing patients with PAD in its early stages is a major challenge faced by many physicians today, due to the limitations associated with the current PAD diagnostic modalities.

Currently, the diagnosis of PAD is established through physical exam, clinical history, and arterial imaging including the ankle brachial index (ABI) - the ratio of the brachial artery blood pressure to the ankle blood pressure. This test serves as the only validated screening tool for PAD and an ABI of ≤0.90 has a 75% sensitivity and 86% specificity. However, the ABI is challenging to use within primary care practice for a few reasons. First, it is not a fully reliable diagnostic tool for PAD. For instance, 25% of diabetic patients have falsely elevated ABI values due to incompressible calcified vessels. Second, since the majority of PAD patients are asymptomatic (60%), primary care physicians rarely refer them for an ABI test for screening. Third, the ABI has geographical limitations as well, as it is only conducted at specialized centers and is not widely available at all clinics. This is particularly true in rural areas and in Indigenous communities - thus compromising health equity.

To validate the challenges physician face with using the ABI as a screening test for PAD, we conducted customer interviews and a survey on 52 primary care physicians within Ontario. Our results confirm that primary care providers face several barriers with accessing and performing the ABI. These barriers include: the extensive training it requires, the length of time it takes in the physician's office (i.e. >15 minutes) and lack of access to specialized equipment (i.e. inaccessible). Furthermore, our data confirm that the ABI measurement is under-utilized and often incorrectly performed within primary care practice - complimenting previously published findings in the literature. Most notably, physicians surveyed in our study were extremely enthusiastic about the potential of a novel blood test for diagnosing PAD. They remarked a blood test that can be ordered/administered during annual physical examinations for patients with cardiovascular risk factors will prove useful in identifying and caring for asymptomatic PAD patients in particular and triaging them to appropriate early vascular care.

Based on the unmet need identified in the survey, our research team discovered, patented, and validated, a novel blood-based biomarker of PAD. In this study, we aim to ascertain the diagnostic accuracy of a blood-based marker for PAD by cross-validating it with the current gold-standard (ABI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
548

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female (sex)
  • At least 40 years or older
  • Willingness to comply with study protocol and provide written informed consent

Exclusion Criteria:

  • Stage 4 and 5 renal failure according to the Kidney Disease Outcomes Quality Initiative clinical guidelines
  • Inability to provide informed consent
  • Acute/recent diagnosis (within past 3 months) of acute coronary syndrome, as defined by the American College of Cardiology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients that Artery Alert correctly diagnoses with PAD by cross validating with the current gold standard
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-Unity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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