Investigating blood vessel repair cells in relation to lipoprotein levels

Lipoprotein (a) and Vascular Regenerative Cell Content

This study looks at whether people with high levels of lipoprotein (a) have fewer blood vessel repair cells compared to those with normal levels 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: NCT06626659 on ClinicalTrials.gov

What this trial studies

This observational study examines the presence and quantity of vascular regenerative cells in individuals with elevated lipoprotein (a) levels compared to those with normal levels. By analyzing peripheral blood samples from participants, the study aims to understand how high lipoprotein (a) may affect cardiovascular health through the depletion of these reparative cells. The research involves a cross-sectional design with two groups: one with elevated lipoprotein (a) and one without, to identify potential mechanisms linking lipoprotein (a) to cardiovascular diseases.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with either elevated lipoprotein (a) levels (≥100 nmol/L) or non-elevated levels (<100 nmol/L).

Not a fit: Patients with life-threatening diseases, uncontrolled hypertension, or significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cardiovascular disease mechanisms and lead to improved risk assessment and management strategies for patients with elevated lipoprotein (a).

How similar studies have performed: While there is ongoing research into lipoprotein (a) and its effects on cardiovascular health, this specific approach to studying vascular regenerative cells in relation to lipoprotein (a) levels is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥18 years of age and ≤80 years of age who meet either of the following criteria:

   1. Elevated Lp(a) (defined as greater than or equal to 100 nmol/L)
   2. Non-elevated Lp(a) (defined as less than 100 nmol/L)
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 provide a peripheral blood sample.
2. Any life-threatening disease expected to result in death within two years of consent.
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 ≥15 x 10\^9/L.
10. Women who are pregnant or nursing.
11. Previously received ribonucleic acid therapy specifically targeting Lp(a).
12. Active infectious disease requiring systemic antibiotic or anti-viral agents.
13. Known acquired immunodeficiency syndrome, such as human immunodeficiency virus.
14. On oral steroid therapy (e.g., prednisone or other corticosteroids) or other immunosuppressive agents (e.g., methotrexate).
15. Treated autoimmune disorders.
16. Participating in another study/trial that is likely to affect the primary outcome.

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, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Subodh Verma, MD — University of Toronto
• Study coordinator: Michael Moroney

Conditions Cardiovascular Diseases; Atherosclerosis Cardiovascular Disease; Ischemic Heart Disease; Dyslipidemia; Lipoprotein; Progenitor cells; Cardiovascular disease