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

October 2, 2024 updated by: Canadian Medical and Surgical Knowledge Translation Research Group

Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease

PAD-VRCE is an observational, cross-sectional, two arm study aimed at determining if the presence of peripheral artery disease (PAD) can influence the number of circulating regenerative cells in blood. From peripheral blood samples, circulating progenitor cell content will be assessed via flow cytometry and compared between individuals with PAD and individuals without PAD. Ultimately, this study plans to evaluate the relationship between PAD, vascular regenerative cell exhaustion and overall cardiovascular health.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Individuals with peripheral artery disease (PAD) have been shown to have poorer cardiovascular health outcomes than the general population. It is believed that the number of people living with PAD is greatly underestimated and furthermore, mortality due to the most severe form of PAD - critical limb ischemia - is increasing. There is a growing body of evidence that the presence of cardiovascular risk factors leads to the imbalance of circulating regenerative cells. The aggregate impact of this regenerative cell exhaustion phenotype is an increased risk of adverse events and progression of disease states.

PAD-VRCE is an observational, cross-sectional, two-arm cohort study aimed at determining the differences in the progenitor cell profiles in the blood of individuals with PAD in comparison to individuals without PAD. We hypothesize that people with PAD will exhibit depleted levels of these progenitor cells defined as vascular regenerative cell exhaustion. VRCE impacts the function of anti-inflammatory cells and associated repair mechanisms within blood vessels, and may contribute to the differential long term outcomes between the two groups.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M6B1N6
      • Scarborough, Ontario, Canada, M1S4N6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Peripheral Artery Disease
20 patients with clinically significant/symptomatic Peripheral Artery Disease defined as symptomatic claudication and an ABI of <0.85
Control Group
20 patients who do not have Peripheral Artery Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in the amount of intracellular reactive oxygen species produced by ALDHhi progenitor cell subsets in individuals with PAD and without PAD
Time Frame: Baseline
Baseline
The difference in the levels of circulating inflammatory and oxidative stress markers in individuals with PAD and without PAD
Time Frame: Baseline
Baseline
The difference in the frequency /absolute count of ALDHhiSSCmid monocytes in individuals with PAD or without PAD
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Investigators

  • Principal Investigator: David A Hess, PhD, Western University, Canada
  • Principal Investigator: Subodh Verma, MD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00080564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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