How inflammation relates to heart health and walking ability in people with peripheral artery disease (PANACEA-O)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.