Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Peripheral Arterial Disease Clinical Trial

— AIIRES  

Official title:

Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590769
• Other study ID #: 16-21018
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2017
• Est. completion date: September 3, 2019

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Claudication
• Claudication, Intermittent
• Iliac Artery Disease
• Inflammation
• Intermittent Claudication
• PAD
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• SFA - Superficial Femoral Artery Stenosis
• Vascular Calcification

Intervention

Drug:
• 18F-FDG
All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 time each week for 3 weeks
Secondary	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.	1 time each week for 3 weeks