Novel Blood Biomarker for Peripheral Arterial Disease
Artery Alert - Revolutionizing the Diagnosis of Peripheral Arterial Disease
1 other identifier
interventional
548
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedOctober 27, 2022
October 1, 2022
2.8 years
October 4, 2022
October 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients that Artery Alert correctly diagnoses with PAD by cross validating with the current gold standard
4 years
Interventions
A device for the measurement of the protein of interest that can be administered in a physician's office without requiring any capital equipment
Eligibility Criteria
You may qualify if:
- Male or female (sex)
- At least 40 years or older
- Willingness to comply with study protocol and provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Surgeon-Scientist, Division of Vascular Surgery, Department of Surgery
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 27, 2022
Study Start
October 1, 2022
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
October 27, 2022
Record last verified: 2022-10