Observing the Role of Inflammation in Peripheral Artery Disease and Its Impact on Heart and Mobility Health: PANACEA-O.
PANACEA-O
Protocol Title Peripheral Arterial Disease and InflammatioN Study Assessing the Cardiovascular and Functional Effects - Observational Study: PANACEA-O
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2025
CompletedFirst Submitted
Initial submission to the registry
January 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMarch 30, 2026
February 1, 2026
7 months
January 9, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-Minute Walk Test (6MWT)
Distance in metres walked in 6 minutes as a measure of functional capacity
Baseline visit
Secondary Outcomes (5)
High-sensitivity C-reactive Protein (hs-CRP)
Baseline visit
Left Ventricular Ejection Fraction (LVEF)
Baseline visit
VascuQoL-6 Total Score
Baseline visit
Systolic Blood Pressure
Baseline visit
Heart Rate
Baseline visit
Study Arms (1)
PAD
Eligibility Criteria
PAD patients recruited from Cardiovascular Clinics at Vancouver General Hospital and McGill University Health Centre
You may qualify if:
- 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:
- 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.
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiology Research UBClead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Fordyce, MD MHS MSc FRCPC
Vancouver General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2026
First Posted
March 30, 2026
Study Start
September 25, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 30, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- At the end of the registry for approximately one year.
- Access Criteria
- The registry investigator will have access to the de-identified dataset after the end of the registry.
The registry data at the end of the registry may lead to the possible design of a larger trial (to calculate the sample size and build data collection instruments).The registry investigator will have access to the de-identified dataset after the end of the registry.