Arterial Imaging of Inflammation and Resolution After Endovascular Surgery (AIIRES)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 1

Conditions

Claudication, Intermittent

PAD

Claudication

Vascular Calcification

SFA - Superficial Femoral Artery Stenosis

Peripheral Arterial Disease

Iliac Artery Disease

Treatments

Drug: 18F-FDG

Study type

Interventional

Funder types

Other

Identifiers

NCT03590769

16-21018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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