How inflammation relates to heart health and walking ability in people with peripheral artery disease (PANACEA-O)
Protocol Title Peripheral Arterial Disease and InflammatioN Study Assessing the Cardiovascular and Functional Effects - Observational Study: PANACEA-O
This project will see if blood inflammation levels are linked with heart health and walking ability in adults with symptomatic peripheral artery disease who get care in Canadian heart clinics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Cardiology Research UBC Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07500610 on ClinicalTrials.gov |
What this trial studies
PANACEA-O is an observational registry enrolling ambulatory adults with symptomatic PAD (Fontaine stage IIa) seen in heart clinics to collect detailed baseline clinical, imaging, blood biomarker (including CRP), and functional walking data. Eligible participants have exertional leg symptoms and objective PAD by ABI ≤0.90, ≥50% peripheral artery stenosis on imaging, or prior lower extremity revascularization. The study excludes people recently treated with immunomodulators or whose walking is limited by non-PAD conditions and does not test any experimental treatment. Data will be used to describe contemporary PAD patients in Canadian clinics and to inform future research on inflammation-targeted interventions.
Who should consider this trial
Good fit: Adults (≥19 years) with symptomatic PAD and intermittent claudication (Fontaine stage IIa), documented ABI ≤0.90 or ≥50% peripheral artery stenosis or prior lower-limb revascularization, who are ambulatory and receiving care at participating heart clinics in Canada.
Not a fit: People who are non‑ambulatory, have walking limitations from other conditions, are on recent immunomodulating therapy, or have more advanced/critical limb ischemia beyond Fontaine stage IIa are unlikely to benefit from this registry.
Why it matters
Potential benefit: If successful, the registry could prompt more routine PAD screening in heart clinics and guide future treatments that target inflammation to improve mobility and cardiovascular outcomes.
How similar studies have performed: Registries and studies have linked elevated inflammatory markers like CRP to worse PAD outcomes, but routine inflammation‑targeted interventions remain limited and this Canadian registry is relatively novel in scope.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Christopher Fordyce, MD MHS MSc FRCPC — Vancouver General Hospital
- Study coordinator: Jackie Chow, BSN
- Email: jackie.chow@vch.ca
- Phone: 604 875-5324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.