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

NCT ID: NCT01196221

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with 30 to 70% carotid artery stenosis

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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AMC

Principal Investigators

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Erik Stroes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Duivenvoorden R, Vanbavel E, de Groot E, Stroes ES, Disselhorst JA, Hutten BA, Lameris 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.

Reference Type BACKGROUND
PMID: 20576811 (View on PubMed)

Other Identifiers

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TIP-R

Identifier Type: -

Identifier Source: org_study_id