Clinical trial NCT01196221: Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.
Official title: Technical Innovation Protocol for Carotid Plaque Imaging by 3.0 Tesla MRI, MRS and Ultrasound: Reproducibility.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-09-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will consist of patients with carotid artery plaques that cause 30% to 70% lumen stenosis. The degree of stenosis will be assessed by the peak systolic velocity end end diastolic velocity near the stenosis measured by ultrasound duplex.

The researchers choose to investigate patients with 30% to 70% carotid artery stenosis for the following reasons: 1. Treatment of patients with carotid artery plaques is based on the amount of lumen stenosis. A stenosis of more than 70% is generally treated surgically by endarterectomy. Doing repeated measurements is only possible in patients not treated surgically. 2. Patients with 30% to 70% carotid artery stenosis are, despite their drug treatment, still at high risk for cardiovascular events.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: NH
Study officials:
affiliation: AIDS Malignancy Consortium
name: Erik Stroes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.