AIIRES: Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT03590769

Collaborator

(none)

Enrollment

Locations

Arm

27.1

Actual Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Claudication, Intermittent Claudication PAD SFA - Superficial Femoral Artery Stenosis Iliac Artery Disease Vascular Calcification	Drug: 18F-FDG	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Health Services Research

Official Title:

Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Sep 3, 2019

Actual Study Completion Date :

Sep 3, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PET/MR using FDG-18 radiotracer

Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer.

Drug: 18F-FDG

All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110
2	UCSF	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Michael S Conte, M.D., University of California, San Francisco
Principal Investigator: Miguel H Pampaloni, M.D., PhD., University of California, San Francisco