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

Launched by CANADIAN MEDICAL AND SURGICAL KNOWLEDGE TRANSLATION RESEARCH GROUP · Oct 2, 2024

Keywords

ClinConnect Summary

The PAD-VRCE trial is studying how peripheral artery disease (PAD) affects the number of special cells in the blood that help repair blood vessels and support heart health. Researchers will compare blood samples from adults with PAD to those without PAD to see if having this condition changes the amount of these helpful cells. The goal is to understand the link between PAD, the health of these regenerative cells, and overall heart health.

Adults aged 18 to 80 may be eligible to participate if they either have symptoms of PAD or have no history of the disease. Participants will need to agree to provide a blood sample and understand what the study involves. During the study, they can expect to undergo some tests related to their blood and health. It's important to note that certain health conditions, like severe heart failure or uncontrolled high blood pressure, may prevent someone from joining the trial. If you or a loved one might be interested in participating, this could be an opportunity to contribute to important research in heart and vascular health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Adults ≥18 and ≤80 years of age who meet either of the following criteria:
• • 1. Clinically significant/symptomatic PAD (defined as symptomatic claudication with and an ankle brachial index of less than 0.85).
• • 2. No history of PAD.
• • 2. Willing and able to provide written informed consent and comply with study procedures.
• Exclusion Criteria:
• • 1. Unable or unwilling to provide written informed consent or to provide a peripheral blood sample.
• • 2. Any life-threatening disease expected to result in death within two years.
• • 3. 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.
• • 4. Uncontrolled hypertension.
• • 5. New York Heart Association Class IV heart failure.
• • 6. Active liver disease or liver dysfunction.
• • 7. Active kidney disease or kidney dysfunction.
• • 8. History of hemorrhagic stroke or other major bleeding disorder.
• • 9. White blood cell count of ≥15x10\^9/L.
• • 10. Active infectious disease requiring systemic antibiotic or anti-viral agents.
• • 11. Known acquired immunodeficiency syndrome, such as Human Immunodeficiency Virus.
• • 12. On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate).
• • 13. Treated autoimmune disorders