Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Study Overview
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Brief Summary
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This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.

Detailed Description
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Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo. Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages. When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site. This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.

Official Title
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Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Conditions
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PAD, Peripheral Arterial Disease, Claudication, Intermittent, Claudication, SFA - Superficial Femoral Artery Stenosis, Iliac Artery Disease, Vascular Calcification

Intervention / Treatment
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* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 40, With resting or exercise ABI <0.9, TBI <0.6 Have claudication or limb threatening ischemia & planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA. Exclusion Criteria: Evidence of active infection Hypersensitivity or allergy to contrast agents Chronic liver disease, renal disease (GFR< 30) or chronic inflammatory disorders Insulin dependent diabetes Presence of metal within subject's body, pacemakers, or defibrillators BMI < 20 or >35 Recent other major surgery or illness within 30 days Use of immunosuppressive medications or steroids History of organ transplantation Pregnancy, or plans to become pregnant, or lactating

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Patient undergoing percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA, will have 18F-FDG-PET scan at the region of interest before intervention, then post-operatively 1 day and 1 week from treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/MR using FDG-18 radiotracer<br>Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer. | Drug: 18F-FDG<br>* All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury. | Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site. | 1 time each week for 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury. | Venipuncture of subject and collection of blood allows measures pro-inflammatory markers and targeted metabolipodimics. | 1 time each week for 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, Peripheral Arterial Disease, Claudication, Intermittent, Claudication, SFA Occlusion, Arterial Occlusion, Iliac Artery Occlusion, Vascular Calcification