About this trial
PAD-VRCE is an observational, cross-sectional, two arm study aimed at determining if the presence of peripheral artery disease (PAD) can influence the number of circulating regenerative cells in blood. From peripheral blood samples, circulating progenitor cell content will be assessed via flow cytometry and compared between individuals with PAD and individuals without PAD. Ultimately, this study plans to evaluate the relationship between PAD, vascular regenerative cell exhaustion and overall cardiovascular health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinically significant/symptomatic PAD (defined as symptomatic claudication with and an ankle brachial index of less than 0.85).
No history of PAD.
Willing and able to provide written informed consent and comply with study procedures.
Disqualifiers
Unable or unwilling to provide written informed consent or to provide a peripheral blood sample.
Any life-threatening disease expected to result in death within two years.
Any malignancy not considered cured (except basal cell carcinoma of the skin). An individual is considered cured if there has been no evidence of cancer recurrence for the five years prior to screening.
Uncontrolled hypertension.
Trial population
Participants will be identified from primary care and cardiology outpatient clinics in the Greater Toronto Area using paper-based and electronic medical records.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD
Secondary outcomes
The difference in the amount of intracellular reactive oxygen species produced by ALDHhi progenitor cell subsets in individuals with PAD and without PAD
The difference in the levels of circulating inflammatory and oxidative stress markers in individuals with PAD and without PAD
The difference in the frequency /absolute count of ALDHhiSSCmid monocytes in individuals with PAD or without PAD
Sponsors and contacts
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