Peripheral Vascular DiseasesPAD-VRCENCT06626646
Vascular Regenerative Cell Exhaustion in Adults With Peripheral Artery Disease (PAD-VRCE)
An observational study of Peripheral Vascular Diseases and Cardiovascular Disease, run by Canadian Medical and Surgical Knowledge Translation Research Group at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases, Cardiovascular Disease, Type 2 Diabetes
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Oct 2024to 5 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 and ≤80 years of age who meet either of the following criteria:
- Clinically significant/symptomatic PAD (defined as symptomatic claudication with and an ankle brachial index of less than 0.85).
- No history of PAD.
- 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 to provide a peripheral blood sample.
- Any life-threatening disease expected to result in death within two years.
- 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.
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- Active kidney disease or kidney dysfunction.
- History of hemorrhagic stroke or other major bleeding disorder.
- White blood cell count of ≥15x10^9/L.
- 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
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
About this study
Official title: 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.
Read the 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. Study investigators 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.
- Conditions
- Peripheral Vascular Diseases, Cardiovascular Disease, Type 2 Diabetes, Peripheral Artery Disease
- Keywords
- Progenitor cells, Cardiovascular disease, Peripheral artery disease
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD
Measured: Baseline
Secondary outcomes (3)
The difference in the amount of intracellular reactive oxygen species produced by ALDHhi progenitor cell subsets in individuals with PAD and without PAD
Measured: Baseline
The difference in the levels of circulating inflammatory and oxidative stress markers in individuals with PAD and without PAD
Measured: Baseline
The difference in the frequency /absolute count of ALDHhiSSCmid monocytes in individuals with PAD or without PAD
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start5 Oct 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subodh Verma, MD, Principal investigator, University of TorontoDavid A Hess, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626646
- Sponsor's protocol ID
- Pro00080564
- Acronym
- PAD-VRCE
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 38355246Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.
PubMed 31477497Hicks CW, Yang C, Ndumele CE, Folsom AR, Heiss G, Black JH 3rd, Selvin E, Matsushita K. Associations of Obesity With Incident Hospitalization Related to Peripheral Artery Disease and Critical Limb Ischemia in the ARIC Study. J Am Heart Assoc. 2018 Aug 21;7(16):e008644. doi: 10.1161/JAHA.118.008644.
PubMed 30369315Shishehbor MH, White CJ, Gray BH, Menard MT, Lookstein R, Rosenfield K, Jaff MR. Critical Limb Ischemia: An Expert Statement. J Am Coll Cardiol. 2016 Nov 1;68(18):2002-2015. doi: 10.1016/j.jacc.2016.04.071. Epub 2016 Sep 28.
PubMed 27692726Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
PubMed 23915883
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Regenerative Cell Exhaustion in Adults With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06626646
- Acronym / sponsor ID
- PAD-VRCE / Pro00080564
- Conditions
- Peripheral Vascular Diseases, Cardiovascular Disease, Type 2 Diabetes, Peripheral Artery Disease
- Keywords
- Progenitor cells, Cardiovascular disease, Peripheral artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research GroupUniversity, hospital or other
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Study investigators 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Adults ≥18 and ≤80 years of age who meet either of the following criteria:
- Willing and able to provide written informed consent and comply with study procedures.
Key exclusion criteria (13 listed)
- Unable or unwilling to provide written informed consent or to provide a peripheral blood sample.
- Any life-threatening disease expected to result in death within two years.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD
Time frame: Baseline
3 secondary outcomes
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
The difference in the levels of circulating inflammatory and oxidative stress markers in individuals with PAD and without PAD
Time frame: Baseline
The difference in the frequency /absolute count of ALDHhiSSCmid monocytes in individuals with PAD or without PAD
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 38355246Krishnaraj 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.
- Background: PubMed 31477497Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.
- Background: PubMed 30369315Hicks CW, Yang C, Ndumele CE, Folsom AR, Heiss G, Black JH 3rd, Selvin E, Matsushita K. Associations of Obesity With Incident Hospitalization Related to Peripheral Artery Disease and Critical Limb Ischemia in the ARIC Study. J Am Heart Assoc. 2018 Aug 21;7(16):e008644. doi: 10.1161/JAHA.118.008644.
- Background: PubMed 27692726Shishehbor MH, White CJ, Gray BH, Menard MT, Lookstein R, Rosenfield K, Jaff MR. Critical Limb Ischemia: An Expert Statement. J Am Coll Cardiol. 2016 Nov 1;68(18):2002-2015. doi: 10.1016/j.jacc.2016.04.071. Epub 2016 Sep 28.
- Background: PubMed 23915883Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subodh Verma, MD principal investigator
University of Toronto
David A Hess, PhD principal investigator
Western University, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases and 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 13 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 21 Aug 2026. 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?
The difference in the frequency / absolute number of circulating primitive myeloid progenitor cells (ALDHhiSSClow) between individuals with PAD and without PAD (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 NCT06626646, which also lists 5 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 21 Aug 2026.