Study to Investigate the Sensitivity and Specificity of 3.0 Tesla MRI for Carotid Artery Plaque
1 other identifier
observational
30
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 20, 2012
May 1, 2012
5.9 years
October 13, 2011
July 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Plaque characteristics as assessed by 3.0 Tesla MRI.
Total plaque volume, plaque calcification volume, plaque haemorrhage volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by 3.0 Tesla MRI
1 month
Secondary Outcomes (2)
Water and lipid content of the plaque as assessed by MRS/3.0T MRI
1 month
Plaque composition and size as assessed by histological analysis
1 month
Study Arms (1)
Patients with ≥70% carotid artery stenosis
Eligibility Criteria
Patients with ≥70% carotid artery stenosis on clinical ultrasound duplex examination, scheduled for endarterectomy in the Athero-Express study.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, 1105AZ, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
October 13, 2011
First Posted
July 2, 2012
Study Start
July 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 20, 2012
Record last verified: 2012-05