Clinical trial NCT03590769: Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
Official title: Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Claudication, Intermittent
Claudication
PAD
SFA - Superficial Femoral Artery Stenosis
Iliac Artery Disease
Vascular Calcification
Keywords: Peripheral Arterial Disease
PAD
Claudication, Intermittent
Claudication
SFA Occlusion
Arterial Occlusion
Iliac Artery Occlusion
Vascular Calcification
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
timeFrame: 1 time each week for 3 weeks
Secondary outcomes:
measure: Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.
timeFrame: 1 time each week for 3 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Michael S Conte, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Miguel H Pampaloni, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
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