Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Investigate the Sensitivity and Specificity of 3.0 Tesla MRI for Carotid Artery Plaque

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01632254
First received: October 13, 2011
Last updated: July 19, 2012
Last verified: May 2012
  Purpose

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. To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores. This non-invasive cross-sectional study, compares carotid parameters of in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology specimens collected at endarterectomy.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Study to Investigate the Sensitivity and Specificity of 3.0 Tesla MRI, MRS and Ultrasound Imaging for Carotid Artery Plaque Dimension and Composition Assessment

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Plaque characteristics as assessed by 3.0 Tesla MRI. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Total plaque volume, plaque calcification volume, plaque haemorrhage volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by 3.0 Tesla MRI


Secondary Outcome Measures:
  • Water and lipid content of the plaque as assessed by MRS/3.0T MRI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The ratio of the integrated lipid peak versus the unsuppressed water peak (expressed as a percentage), as assessed by MRS.

  • Plaque composition and size as assessed by histological analysis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Plaque size, morphology and phenotype (presence of collagen, smooth muscle cells, calcifications, macrophages, thrombus and fat), as assessed by histology analysis.


Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with ≥70% carotid artery stenosis

Detailed Description:

Atherosclerosis is a protracted and in fact lifelong progressive disease. Over time, lipids accumulate in the artery wall forming fatty streaks, which eventually can develop into atherosclerotic plaques (1). The later stages of the process, from quiescent atherosclerotic plaque to an active plaque, have a high risk of triggering acute vascular events, such as myocardial infarction and stroke (1).

Much effort has been put in the development of novel drugs aimed to prevent cardiovascular disease. Low Density Lipoprotein cholesterol (LDL-C) lowering drugs, in particularly statins, play a pivotal role. The hypothesis that serum lipid lowering results in decrease of lipid accumulation in the arterial wall and thus atherogenesis, has formed the basis for successful drug developing strategies (1;2).

To draw valid conclusions on determinants of disease and effectiveness of lipid modifying therapeutic intervention, imaging of atherosclerosis can be used as a validated tool to assess efficacy of novel compounds (3;4).

Although imaging arterial wall dimensions by B-mode ultrasound and intra-vascular ultrasound have proven their value, longitudinal data of the effects of cardiovascular drugs on arterial wall and plaque composition, in particular of vulnerable plaques with lipid rich necrotic cores (LRNC), are scarce.

Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are non-invasive imaging modalities that can potentially image plaque composition in-vivo in human carotid arteries. MRI image acquisition at various weightings enables visualisation of plaque composition. Calcification, haemorrhage, fibrous cap and lipid rich necrotic cores can readily be distinguished, providing information on plaque vulnerability. MRS gives a spectrum of resonances, affording detection of specific chemical components through their inherent frequency shift relative to water (5). In image guided MRS, an MR image can be utilized to image and localize a plaque. Proton spectra can then be collected from these plaques, such that the specific proton resonances of lipid components in a mobile state, including cholesterol ester (CE), can be identified (6).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with ≥70% carotid artery stenosis on clinical ultrasound duplex examination, scheduled for endarterectomy in the Athero-Express study.

Criteria

Inclusion Criteria:

  • Patients are to meet the inclusion criteria of the Athero-Express study.
  • These patients are eligible to undergo carotid endarterectomy in either the St. Antonius Hospital, Nieuwegein.
  • Willing and able to undergo non-invasive MRI, MRS and ultrasound examinations in the Academic Hospital Center, Amsterdam.
  • Signed informed consent

Exclusion Criteria:

  • Patients not suitable for MRI (e.g. metal in the body, as a result of pacemaker or artificial cardiac valves); claustrophobia; surgery performed in the neck area of the carotid measurements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632254

Contacts
Contact: Erik Stroes, MD PhD +31205666612 e.s.stroes@amc.uva.nl
Contact: Diederik van Wijk, MD +31205662377 D.F.vanWijk@amc.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Erik Stroes, MD PhD    +31205666612    e.s.stroes@amc.uva.nl   
Contact: Diederik van Wijk, MD    +31205662377    D.F.vanWijk@amc.nl   
Principal Investigator: Erik Stroes, MD PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: E.S.stroes, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01632254     History of Changes
Other Study ID Numbers: TIP-H
Study First Received: October 13, 2011
Last Updated: July 19, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014