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

November 25, 2020 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
      • San Francisco, California, United States, 94143
        • UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 1 time each week for 3 weeks
Venipuncture of subject and collection of blood allows measures pro-inflammatory markers and targeted metabolipodimics.
1 time each week for 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

September 3, 2019

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-21018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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