Examining regenerative cells in adults with and without peripheral artery disease

Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease

This study looks at the differences in certain blood cells between adults with peripheral artery disease and those without to see how it might affect heart health.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 2 sites (North York, Ontario and 1 other locations)
• Trial ID: NCT06626646 on ClinicalTrials.gov

What this trial studies

This observational study investigates the differences in circulating regenerative cells between adults with peripheral artery disease (PAD) and those without. By analyzing peripheral blood samples through flow cytometry, the study aims to assess the levels of progenitor cells and their potential exhaustion in individuals with PAD. The research seeks to understand how PAD may impact cardiovascular health and the implications of regenerative cell profiles on disease progression and outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80, either diagnosed with symptomatic PAD or without any history of PAD.

Not a fit: Patients with life-threatening diseases expected to result in death within two years or those with uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the role of regenerative cells in cardiovascular health, potentially leading to improved management strategies for patients with PAD.

How similar studies have performed: While this study explores a specific aspect of regenerative cell profiles in PAD, similar studies have shown promising results in understanding the relationship between regenerative cells and cardiovascular conditions.

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

Where this trial is running

North York, Ontario and 1 other locations

• North York Diagnostic and Cardiac Centre — North York, Ontario, Canada (Recruiting)
• Diagnostic Assessment Centre — Scarborough Village, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Subodh Verma, MD — University of Toronto
• Study coordinator: Jack Casey

Conditions Peripheral Vascular Diseases; Cardiovascular Disease; Type 2 Diabetes; Peripheral Artery Disease; Progenitor cells; Cardiovascular disease; Peripheral artery disease