Metabolic Imaging in Carotid Atherosclerosis

NCT01674257 | Completed

• 2 other identifiers: MICA-V1.3PG/12/8/29371
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with hardening of the neck arteries due to undergo surgery to remove the hardened areas. The investigators will then be able to compare the hot spots found on these scans with what the investigators can see in the removed specimens under the microscope in the laboratory. This will give investigators insight into the value of PET CT and MRI as tools for assessing atherosclerosis. It will also provide the investigators with new information relating to the underlying processes that give rise to atherosclerosis and will pave the way for the future development of new treatments.

Conditions

Atherosclerosis; Stroke

Keywords

Atherosclerosis; Stroke; Positron-emission tomography; Ferumoxytol; Magnetic resonance imaging; Genetics; Calcification; Inflammation; Flurodeoxyglucose F18; Radiopharmaceuticals

Outcome Measures

Primary Outcomes (1)

• The Standardized Uptake Value (SUV) for 18F-Fluoride of the ipsilateral carotid artery

  The mean and maximum SUV (using 18F-NaF) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner. The SUV is a validated quantitative assessment of PET radiotracer uptake.

  1-2 days after PET/CT scan

Secondary Outcomes (8)

• The SUV of 18F-Flurodeoxyglucose on PET/CT of the ipsilateral carotid artery

  1-2 days after PET/CT scan

• A correlation between the ipsilateral carotid SUV of 18F-Flurodeoxyglucose and tissue markers of inflammation and apoptosis.

  Approximately 1 month after PET/CT scan

• A correlation between ipsilateral carotid SUV of 18F-Fluoride and the gene expression characteristics of excised plaque.

  Approximately 1 month after the PET/CT scan

• A correlation between the ipsilateral carotid SUV of 18F-Fluoride and tissue markers of apoptosis and calcification.

  Approximately 1 month after the PET/CT scan

• The presence or absence of USPIO (ultra-small superparamagnetic particles of iron oxide) uptake on MRI (magnetic resonance image) within the ipsilateral carotid artery compared to its contralateral partner.

  1-2 days after MRI scan

Study Arms (1)

Carotid Endarterectomy

Patients due to undergo carotid endarterectomy for symptomatic carotid artery stenosis will undergo an 18F-Fluoride PET/CT, an 18F-Flurodeoxyglucose PET/CT and a USPIO (ferumoxytol)-enhanced MRI scan (2 MRI scans).

Other: USPIO (ferumoxytol)-enhanced MRI scan; Radiation: 18f-Fluoride PET/CT scan; Radiation: 18F-Flurodeoxyglucose PET/CT scan

Interventions

USPIO (ferumoxytol)-enhanced MRI scan OTHER

Two separate MRI scans will form this intervention. A baseline scan followed by an infusion of USPIO (ferumoxytol), followed by another MRI scan.

Carotid Endarterectomy

18f-Fluoride PET/CT scan RADIATION

Carotid Endarterectomy

18F-Flurodeoxyglucose PET/CT scan RADIATION

Carotid Endarterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for carotid endarterectomy for symptomatic carotid artery stenosis.

You may qualify if:

• Patients with carotid stenosis due to undergo carotid endarterectomy.

You may not qualify if:

• Patients with new stroke and a modified Rankin score \>3
• Chronic Kidney Disease with eGFR of \<30 mL/min/1.73m2
• Pregnant women
• Poorly controlled diabetes mellitus (HbA1c \> 8.5%) or diabetes mellitus requiring insulin
• Prior ipsilateral carotid intervention
• Prior neck irradiation
• Inability to tolerate the supine position
• Participation in the study would result in delay to surgery
• Psychiatric illness/social situations that would limit compliance with study requirements
• Specific contraindications to MRI (e.g. pacemaker)
• History of allergic reaction attributed to ferumoxytol or similar
• Known or suspected iron overload (genetic haemochromatosis or history of multiple transfusions)
• History of allergic reaction attributed to 18F-FDG or 18F-NaF or similar
• History of allergic reaction to iodine or iodine-based contrast media

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Clinical Research Imaging Centre

Edinburgh, EH16 4TJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and excised carotid atheroma

MeSH Terms

Conditions

Atherosclerosis; Stroke; Calcinosis; Inflammation

Interventions

ferumoxtran-10

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David E Newby, DSc

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: October 10, 2012
• Primary Completion: June 30, 2014
• Study Completion: July 31, 2015
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

GB (1)