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Cardiovascular DiseasesLp(a)-VRCENCT06626659

Lipoprotein (a) and Vascular Regenerative Cell Content

An observational study of Cardiovascular Diseases and Atherosclerosis Cardiovascular Disease, run by Canadian Medical and Surgical Knowledge Translation Research Group at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lp(a)-VRCE is an observational, cross sectional study looking at vessel reparative stem cell content in people with and without elevated lipoprotein (a) [Lp(a)]. Specifically, the type and number of these cells in peripheral blood samples will be measured in participants with Lp(a) ≥100 nmol/L and compared to… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
How many people
40 participants
Where
2 sitesCanada
Study dates
5 Oct 2024to 3 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be identified from primary care and cardiology outpatient clinics in the Greater Toronto Area using paper-based and electronic medical records.

Who may be able to join

  • Adults ≥18 years of age and ≤80 years of age who meet either of the following criteria:
  • Elevated Lp(a) (defined as greater than or equal to 100 nmol/L)
  • Non-elevated Lp(a) (defined as less than 100 nmol/L)
  • Willing and able to provide written informed consent and comply with study procedures.

Who cannot join

  • Unable or unwilling to provide written informed consent or provide a peripheral blood sample.
  • Any life-threatening disease expected to result in death within two years of consent.
  • 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.
  • New York Heart Association Class IV heart failure.
  • Active liver disease or liver dysfunction.
Show all 16Show fewer
  • Active kidney disease or kidney dysfunction.
  • History of hemorrhagic stroke or other major bleeding disorder.
  • White blood cell count ≥15 x 10^9/L.
  • Women who are pregnant or nursing.
  • Previously received ribonucleic acid therapy specifically targeting Lp(a).
  • Active infectious disease requiring systemic antibiotic or anti-viral agents.
  • Known acquired immunodeficiency syndrome, such as human immunodeficiency virus.
  • On oral steroid therapy (e.g., prednisone or other corticosteroids) or other immunosuppressive agents (e.g., methotrexate).
  • Treated autoimmune disorders.
  • Participating in another study/trial that is likely to affect the primary outcome.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B1N6

  • Diagnostic Assessment Centre

    Scarborough Village, Ontario, M1S4N6

Other trials in Canada

About this study

Lp(a)-VRCE is an observational, cross sectional study looking at vessel reparative stem cell content in people with and without elevated lipoprotein (a) [Lp(a)]. Specifically, the type and number of these cells in peripheral blood samples will be measured in participants with Lp(a) ≥100 nmol/L and compared to participants with Lp(a) < 100 nmol/L. Determining the presence or absence of specific cells with blood vessel repair capacity in participants with high Lp(a) will further our knowledge of potential mechanisms through which Lp(a) influences cardiovascular health.

Read the detailed description

Lipoprotein (a) [Lp(a)] is an independent, genetically determined, causal risk factor for the development of atherosclerotic cardiovascular disease. It is estimated that 20-30% of the global population have elevated Lp(a) and recent multinational guideline endorsements strongly advise the routine measuring of Lp(a), at least once in a person's life. Current Lp(a) risk level thresholds are described as <75 nmol/L for low risk and >125 nmol/L for high risk individuals. Despite ongoing clinical trials, there exists no approved therapeutic medication to specifically lower Lp(a).

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.

Keywords
Lipoprotein (a), Progenitor cells, Cardiovascular disease
Medical subject headings
Cardiovascular Diseases, Myocardial Ischemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06626659
Study groupRoleWhat they receive
Elevated Lp(a)Individuals with an Lp(a) level greater than or equal to 100 nmol/L
Non-elevated Lp(a)Individuals with an Lp(a) level less than 100 nmol/L

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the frequency or absolute number of circulating ALDHhiSSClo primitive myeloid progenitor cells between individuals with elevated Lp(a) and individuals with non-elevated Lp(a)

    Measured: Baseline

Secondary outcomes (1)

  1. Difference in the frequency/absolute count of ALDHhiSSCmid monocytes between individuals with elevated Lp(a) and individuals with non-elevated Lp(a)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start5 Oct 2024
  3. Primary completion3 Dec 2024
  4. Study completion3 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06626659
Sponsor's protocol ID
Pro00080565
Acronym
Lp(a)-VRCE
Status last verified
Dec 2025
First submitted
2 Oct 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34647487

  • 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.

    PubMed 30847424

  • 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.

    PubMed 37773589

  • 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.

    PubMed 38874618

  • 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.

    PubMed 38355246

  • 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.

    PubMed 36036785

  • 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.

    PubMed 40883226

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Atherosclerosis Cardiovascular Disease, run by Canadian Medical and Surgical Knowledge Translation Research Group at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the frequency or absolute number of circulating ALDHhiSSClo primitive myeloid progenitor cells between individuals with elevated Lp(a) and individuals with non-elevated Lp(a) (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06626659, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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