Recruiting

Observational Study

Sponsor:

Cardiology Research UBC

Code:

NCT07500610

Conditions

Peripheral Vascular Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This registry aims to collect detailed information about people in Canada who have Peripheral Artery Disease (PAD) and are receiving care in heart clinics while still able to walk and live in the community. Researchers want to better understand what these patients are like at the start of their care and looking at their general health, levels of inflammation in their bodies, and how well they can move and function in daily life.

The results of this study will help healthcare providers better understand what PAD looks like in today's Canadian heart clinics. It will also help guide future research studies that focus on inflammation and PAD. The researchers believe that PAD patients can be routinely recruited from these clinics, and that most of these patients will have high levels of inflammation (shown by high blood CRP levels) and poor physical ability when they first join. The findings will show that there is a strong need to regularly check for PAD in heart clinics so that patients can be identified early and offered new treatments in the future and especially treatments that may help reduce inflammation.

Conditions

Peripheral Vascular Disease

Study ID

NCT07500610

Start date

Sep 25, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >/= 19 years of age
  • Ability to provide informed consent before any trial-related activities
  • Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa meeting all of the following:

1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.
2. Ankle-brachial-index (ABI) equal to or below 0.90 (the leg with lowest index is chosen in case of bilateral disease) or ≥ 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound, or a history of lower extremity revascularization

Exclusion Criteria:

  • Current or previous treatment with any immunomodulating agent within 90 days prior to the day of screening.
  • Walking ability limited by conditions other than PAD
  • Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).
  • Vascular revascularisation procedure for PAD of any kind 180 days prior to the day of screening.
  • Planned arterial revascularisation known on the day of screening.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.
  • Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.
  • Signs/symptoms of critical limb ischemia (leg gangrene, rest pain, ischemic wounds, etc)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

PAD

Primary outcome measure

  • 6-Minute Walk Test (6MWT) [ Time Frame: Baseline visit ]

Central Contacts and Locations

Central contacts

Jackie Chow, BSN

604 875-5324jackie.chow@vch.ca

Robyn Szchory, BSN

604 875-5120robyn.szchory@ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jackie Chow, BSN

604 875-5324jackie.chow@vch.ca

Bianca Marginean, BSc, MM

604 875-4111bianca.marginean@ubc.ca

Principal Investigator:

Christopher Fordyce, MD MHS MSc FRCPC

More Information

Sponsor

Cardiology Research UBC

Last update posted

Mar 30, 2026

Last verified

Feb, 2026

Keywords

  • peripheral vascular disease
  • inflammation
  • CRP
  • claudication
  • ABI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2026-03-30.