RECRUITINGOBSERVATIONAL

Observing the Role of Inflammation in Peripheral Artery Disease and Its Impact on Heart and Mobility Health: PANACEA-O.

Protocol Title Peripheral Arterial Disease and InflammatioN Study Assessing the Cardiovascular and Functional Effects - Observational Study: PANACEA-O

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age \>/= 19 years of age - Ability to provide willing to sign a consent form 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Locations (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada