Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.

Atherosclerosis Clinical Trial

Official title:

Technical Innovation Protocol for Carotid Plaque Imaging by 3.0 Tesla MRI, MRS and Ultrasound: Reproducibility.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196221
• Other study ID #: TIP-R
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 7, 2010
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify the plaque composition and lipid content of plaques and will have the potential for repeated in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC). For plaque composition imaging by MRI the researchers aim to increase scan resolution and decrease scan time. For quantifying plaque lipid content the researchers aim to develop an MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have carotid artery plaques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients, with 30 to 70% carotid artery stenosis on ultrasound duplex, who will not go for endarterectomy.

Exclusion Criteria:

• Metal in the body, as a result of e.g. pacemaker or artificial cardiac valves; claustrophobia; surgery performed in the area of measurement (Carotid artery region); Cardiac arrhythmias.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	NH

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Duivenvoorden R, Vanbavel E, de Groot E, Stroes ES, Disselhorst JA, Hutten BA, Laméris JS, Kastelein JJ, Nederveen AJ. Endothelial shear stress: a critical determinant of arterial remodeling and arterial stiffness in humans--a carotid 3.0-T MRI study. Circ Cardiovasc Imaging. 2010 Sep;3(5):578-85. doi: 10.1161/CIRCIMAGING.109.916304. Epub 2010 Jun 24. Erratum in: Circ Cardiovasc Imaging. 2011 Mar 1;4(2):e3. — View Citation