Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease (PAD-VRCE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCanadian Medical and Surgical Knowledge Translation Research Group

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: Peripheral Artery Disease
Group B: Control Group

Trial outcomes

Primary outcomes

1

The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD

Time frame
Baseline

Secondary outcomes

1

The difference in the amount of intracellular reactive oxygen species produced by ALDHhi progenitor cell subsets in individuals with PAD and without PAD

Time frame
Baseline
2

The difference in the levels of circulating inflammatory and oxidative stress markers in individuals with PAD and without PAD

Time frame
Baseline
3

The difference in the frequency /absolute count of ALDHhiSSCmid monocytes in individuals with PAD or without PAD

Time frame
Baseline

Other outcomes

Sponsors and contacts

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