Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2024-10-05
2024-12-03
Brief Summary
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Detailed Description
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Vascular regenerative cell exhaustion (VRCE) is described as the depletion of circulating pro-vascular reparative cells responsible for angiogenesis, vasculogenesis and arteriogenesis. Evidence in recent years has implicated VRCE as a novel mechanistic factor contributing to the aberrant cardiometabolic state present in type 2 diabetes, obesity, and in people of South Asian descent. It has been demonstrated that the VRCE phenotype can be reversed by treatment with sodium glucose co-transporter 2 inhibitors or bariatric surgery.
Lp(a)-VRCE is a cross-sectional, observational, two arm study enrolling 20 patients with elevated Lp(a) (≥100 nmol/L) and 20 patients with non-elevated Lp(a) (\<100 nmol/L). From peripheral blood, mononuclear cells are isolated and enumerated via a multi-parametric flow cytometry assay utilizing aldehyde dehydrogenase activity and side scatter properties. The hypothesis is that people with elevated Lp(a) have comparatively different progenitor cell phenotypes to people with normal Lp(a) levels.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Elevated Lp(a)
Individuals with an Lp(a) level greater than or equal to 100 nmol/L
No interventions assigned to this group
Non-elevated Lp(a)
Individuals with an Lp(a) level less than 100 nmol/L
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Canadian Medical and Surgical Knowledge Translation Research Group
OTHER
Responsible Party
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Principal Investigators
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Subodh Verma, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
David A Hess, PhD
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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North York Diagnostic and Cardiac Centre
North York, Ontario, Canada
Diagnostic Assessment Centre
Scarborough Village, Ontario, Canada
Countries
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References
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Reyes-Soffer G, Ginsberg HN, Berglund L, Duell PB, Heffron SP, Kamstrup PR, Lloyd-Jones DM, Marcovina SM, Yeang C, Koschinsky ML; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; and Council on Peripheral Vascular Disease. Lipoprotein(a): A Genetically Determined, Causal, and Prevalent Risk Factor for Atherosclerotic Cardiovascular Disease: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol. 2022 Jan;42(1):e48-e60. doi: 10.1161/ATV.0000000000000147. Epub 2021 Oct 14.
Terenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb.
Bakbak E, Verma S, Krishnaraj A, Quan A, Wang CH, Pan Y, Puar P, Mason T, Verma R, Terenzi DC, Rotstein OD, Yan AT, Connelly KA, Teoh H, Mazer CD, Hess DA. Empagliflozin improves circulating vascular regenerative cell content in people without diabetes with risk factors for adverse cardiac remodeling. Am J Physiol Heart Circ Physiol. 2023 Nov 1;325(5):H1210-H1222. doi: 10.1152/ajpheart.00141.2023. Epub 2023 Sep 29.
Park B, Krishnaraj A, Teoh H, Bakbak E, Dennis F, Quan A, Hess DA, Verma S. GLP-1RA therapy increases circulating vascular regenerative cell content in people living with type 2 diabetes. Am J Physiol Heart Circ Physiol. 2024 Aug 1;327(2):H370-H376. doi: 10.1152/ajpheart.00257.2024. Epub 2024 Jun 14.
Krishnaraj A, Bakbak E, Teoh H, Pan Y, Firoz IN, Pandey AK, Terenzi DC, Verma R, Bari B, Bakbak AI, Kunjummar SP, Yanagawa B, Connelly KA, Mazer CD, Rotstein OD, Quan A, Bhatt DL, McGuire DK, Hess DA, Verma S. Vascular Regenerative Cell Deficiencies in South Asian Adults. J Am Coll Cardiol. 2024 Feb 20;83(7):755-769. doi: 10.1016/j.jacc.2023.12.012.
Kronenberg F, Mora S, Stroes ESG, Ference BA, Arsenault BJ, Berglund L, Dweck MR, Koschinsky M, Lambert G, Mach F, McNeal CJ, Moriarty PM, Natarajan P, Nordestgaard BG, Parhofer KG, Virani SS, von Eckardstein A, Watts GF, Stock JK, Ray KK, Tokgozoglu LS, Catapano AL. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J. 2022 Oct 14;43(39):3925-3946. doi: 10.1093/eurheartj/ehac361.
Moroney M, Casey JH, Teoh H, Krishnaraj A, Pan Y, Quan A, Patel SK, Dennis F, He AZ, Park B, Verma R, Misner E, Seguchi R, Hassan SMA, Dennis CJ, Meglis G, Pandey A, Butler J, Mazer CD, Byrne RA, Koschinsky ML, Hess DA, Verma S. Vascular regenerative deficiencies in people with elevated lipoprotein(a): the Lp(a)-VRCE CardioLink-16 translational study. Cardiovasc Res. 2025 Nov 22;121(14):2127-2130. doi: 10.1093/cvr/cvaf142.
Other Identifiers
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Pro00080565
Identifier Type: -
Identifier Source: org_study_id