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

Primary Purpose

Peripheral Arterial Disease, Claudication, Intermittent, Claudication

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, PAD, Claudication, Intermittent, Claudication, SFA Occlusion, Arterial Occlusion, Iliac Artery Occlusion, Vascular Calcification

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Francisco General Hospital
  • UCSF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MR using FDG-18 radiotracer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 16, 2018
Last Updated
November 25, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03590769
Brief Title
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
Acronym
AIIRES
Official Title
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/MR using FDG-18 radiotracer
Arm Type
Experimental
Arm Description
Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Intervention Description
All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG
Primary Outcome Measure Information:
Title
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
Description
Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.
Time Frame
1 time each week for 3 weeks
Secondary Outcome Measure Information:
Title
Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.
Description
Venipuncture of subject and collection of blood allows measures pro-inflammatory markers and targeted metabolipodimics.
Time Frame
1 time each week for 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Conte, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel H Pampaloni, M.D., PhD.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

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