- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677963
Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation
Contrast-enhanced Ultrasound and Magnetic Resonance Imaging for the Evaluation of Neovascularisation in Carotid Artery Plaques
The first goal of this study is to investigate whether CE-US is able to accurately identify and quantify neovascularisation in carotid artery plaques. Since this is one of the first studies systematically evaluating the ability of ultrasound in combination with air bubbles to evaluate neovascularisation in carotid artery plaques, the examination will be performed twice with an interval of 1/2 hour on the day before surgery, thus studying the reliability of the method.
The second goal of this study is to investigate whether MRI at 3.0 T with a custom-designed 3T carotid coil, using a recently developed pulse sequence, is able to accurately identify and quantify neovascularisation. And the third goal of this study is to make an intermodality comparison of CE-US and MRI regarding their ability to identify and quantify plaque neovascularisation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 HX
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with a >70% carotid artery stenosis who are scheduled for carotid endarterectomy. Such subjects will be eligible if the subject's attending physician of the department of surgery concurs with this assessment.
- Age 18 years or older
- Informed consent by signing informed consent form regarding this study
Exclusion Criteria:
- Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
- Acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
- Right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome.
- Pregnant and lactating women
- Documented allergy to contrast media or a renal clearance <30 ml/minute
- Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Patients with symptomatic 70-99% carotid stenosis who are operated on.
|
CE-US, using 2 x 2.4 ml sulphur hexafluoride and MRI, using 1 x 0.2 ml/kg gadopentate dimeglumine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plaque neovascularization at contrast-enhanced ultrasound and MRI
Time Frame: Cross-sectional
|
Cross-sectional
|
Collaborators and Investigators
Investigators
- Principal Investigator: Werner H Mess, MD, PhD, Department of Clinical Neurophysiology, University Medical Center Maastricht
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Carotid Artery Diseases
- Metaplasia
- Carotid Stenosis
- Neovascularization, Pathologic
- Atherosclerosis
Other Study ID Numbers
- MEC 08-2-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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