Imaging of Plaque With Magnetic Resonance Imaging (MRI)

NCT00115856 | Completed

• 1 other identifier: 2001P-000114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and refine the use of an intravascular wire to image plaque in the aorta, iliac and femoral artery using MRI. This project aims to use this increased resolution to identify the features within the plaque that is known to be associated with increased risk of plaque and vessel occlusion. The hypothesis is Intravascular MRI can detect and measure changes in response to therapy over time in the critical features in plaques in peripheral arteries of patients with atherosclerosis.

Conditions

Arterial Occlusive Disease

Keywords

Arterial Disease

Study Arms (1)

Subjects studied

NO INTERVENTION

Single arm exploratory feasibility safety and efficacy study of MRI to image atherosclerosis in arteries

Procedure: Intravascular MRI

Interventions

Intravascular MRI PROCEDURE

Arterial imaging of atherosclerosis

Subjects studied

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (aged 25-80) seen at the Brigham and Women's Hospital (BWH) clinic who have known arterial disease who consent to cannulation of the femoral artery for this research.
• Patients in the prespecified age group who are scheduled to undergo a clinically indicated heart or peripheral catheterization at the BWH catheterization (cath) lab who will have a tube (sheath) already positioned in their femoral artery
• Patient must be in stable condition with regard to symptoms, vital signs and the monitored electrocardiogram

You may not qualify if:

• Unstable symptoms, vital signs or electrocardiogram after the heart cath
• Any complications during the heart cath (eg., bleeding, angina, arrhythmias, technical difficulties cannulating the femoral artery)
• Creatinine \>2.0mg/dl
• Pregnancy
• Contraindications to anticoagulation
• Patients with a metal implant, pacemaker, cardiac defibrillator, metal fragments in the eye, bullets/metal objects in the body

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Peter Ganz MD: collaborator

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew Selwyn, MD

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 26, 2005
• First Posted: June 27, 2005
• Study Start: January 1, 2001
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

US (1)