Non-Invasive Imaging of Atherosclerosis

NCT01418313 | Completed

• 2 other identifiers: GCO 01-1032R01HL071021
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI), dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for the detection and risk stratification of patients with atherosclerosis.

Conditions

Atherosclerosis

Keywords

Atherosclerosis; Non-invasive imaging; Magnetic Resonance Imaging; MRI; Positron Emission Tomography; PET/CT; PET/MRI; Inflammation; Neovascularization

Outcome Measures

Primary Outcomes (1)

• Correlation between imaging and biomarkers of atherosclerosis

  R correlation coefficient

  5 years

Secondary Outcomes (2)

• DCE-MRI kinetic parameters

  3 years

• FDG uptake parameters

  3 years

Study Arms (3)

DCE-MRI

Magnetic resonance imaging (MRI) with and without FDA approved contrast agents: MRI is a non invasive imaging technique used to visualize the internal structure of the body in detail. The MRI machine is an oversized magnet that is always on. It will be used in this study to provide anatomical and functional (MRI with contrast) information about atherosclerotic plaques.

PET/CT and PET/MR

Positron emission tomography (PET)/ computer tomography (CT): PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. Nowadays PET imaging is most useful in combination with anatomical imaging, such as CT scanners, thereby PET scanners are now available with integrated high-end multi-detector row CT scanners. Because the two scans can be performed in immediate sequence during the same session and with the patient not changing position between the two scans, areas of abnormality on PET images can be directly correlated with anatomy on the CT images.

PET/MR

Positron emission tomography (PET)/MRI: PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. To avoid the additional radiation deriving from the CT scan during PET/CT imaging, nowadays PET imaging can be paired with MR anatomical images.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects in the New York area referred by primary care physician, or recruited through Lifeline Screening or ResearchMatch.org, or Mount Sinai Broadcast emails and flyers.

You may qualify if:

• Volunteers with carotid artery disease who are MRI and CT compatible.
• All subjects will have either a
• clinical diagnosis of atherosclerosis,
• and/or risk factors
• and/or family history of disease

You may not qualify if:

• Glomerular filtration rate \<30mg/ml (for MRI with contrast)
• Subjects who have any ferromagnetic implants (e.g. aneurysm clip, ICD, pacemaker, etc.) or a condition that may be contraindicated for the MRI procedure (e.g. claustrophobia )
• Pregnant patients will be excluded from the present study.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institutes of Health (NIH): collaborator
• NYU Langone Health: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Endarterectomy Specimens

MeSH Terms

Conditions

Atherosclerosis; Inflammation; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metaplasia

Study Officials

• Zahi A Fayad, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

US (1)