Carotid Artery StenosisNCT00677963
Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation
A study testing sulphur hexafluoride, gadopentate dimeglumine in people with Carotid Artery Stenosis and Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Atherosclerosis
- What is being tested?
- sulphur hexafluoride, gadopentate dimeglumine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: 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.
Read the detailed description
Atherosclerosis is a systemic disease of the large arteries and the leading cause of death in Western society. The development of atherosclerosis involves the accumulation of lipids, cells and extracellular matrix in the blood vessel wall. It is a progressive disease characterized by the formation of a fibrous cap by smooth muscle cell proliferation and migration, and the development of a necrotic/lipid core. This core develops due to the accumulation of lipids and apoptosis of lipid-loaded macrophages. In this process the intima, the innermost layer of the blood vessel, thickens. This will lead to narrowing of the lumen and obstruction of blood flow. The developed lesion of the vessel wall may become vulnerable to rupture of the fibrous cap. Cap rupture exposes the necrotic core to the blood leading to the formation of a thrombus. The thrombus may fully or partially obstruct the lumen and cause cardiovascular complications, such as myocardial infarction or stroke. Although atherosclerosis forms the origin of most cardiovascular diseases, at present much remains unknown of the atherogenic process. Therefore, it is essential that research is done to discover novel mechanisms of atherosclerotic development. Intimal neovascularisation has recently drawn much attention as a novel factor, likely contributing to atherosclerotic plaque growth and rupture. Neovascularisation occurs when the intima thickens and is associated with stenosis, plaque inflammation and hemorrhage. Because increased amount of neovascularisation may be associated with increased risk for stroke, it would be highly desirable to identify plaque neovascularisation by noninvasive imaging. At present, imaging of neovascular development in atherosclerotic lesions with conventional ultrasound is not feasible, since the vessel diameter is well below the resolution capacity of currently available ultrasound systems. Since almost a decennium, contrast-enhanced ultrasound (CE-US) with gaseous ultrasound contrast agents has been used for research purposes but is now also widely commercially available and registered for clinical use, which can be done safely. With the help of such a gaseous contrast medium containing air bubbles smaller than erythrocytes (microbubbles) it might be possible to depict neovascularisation in a carotid artery plaque, due to the strong signal that will be evoked even by a small number of air bubbles as compared to the signal from the surrounding tissue. So, the intensity increase of the ultrasound signal from the carotid artery plaque after administration of microbubbles might reflect the amount of neovascularisation. Until now, only case reports concerning this technique have been published, especially no comparison with histology has been performed. So, 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. Magnetic resonance imaging (MRI) is well suited for evaluating carotid plaques; it is widely available, provides excellent soft tissue contrast, multiplanar imaging capability, and is free of ionising radiation. Multisequence MRI has shown to be able to detect different carotid plaque components in vivo. However, only very little experience exists in identifying neovascularisation by MRI. Also, newer MRI systems (>1.5 T), newer coil systems, and better pulse sequences have recently become available. Therefore, 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. Finally, 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.
- Conditions
- Carotid Artery Stenosis, Atherosclerosis
- Being tested
- sulphur hexafluoride, gadopentate dimeglumine
- Keywords
- carotid, atherosclerosis, arteriosclerosis, plaque, neovascularization, carotid endarterectomy
- Medical subject headings
- Carotid Stenosis, Atherosclerosis, Arteriosclerosis, Plaque, Amyloid, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulphur hexafluoride, gadopentate dimeglumineDrug
CE-US, using 2 x 2.4 ml sulphur hexafluoride and MRI, using 1 x 0.2 ml/kg gadopentate dimeglumine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients with symptomatic 70-99% carotid stenosis who are operated on. Receives: Drug: sulphur hexafluoride, gadopentate dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque neovascularization at contrast-enhanced ultrasound and MRI
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Werner H Mess, MD, PhD, Principal investigator, Department of Clinical Neurophysiology, University Medical Center Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677963
- Sponsor's protocol ID
- MEC 08-2-019
- Status last verified
- Apr 2011
- First submitted
- 8 May 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound and Magnetic Resonance Imaging for the Evaluation of Neovascularisation in Carotid Artery Plaques
- ClinicalTrials.gov ID
- NCT00677963
- Acronym / sponsor ID
- MEC 08-2-019
- Conditions
- Carotid Artery Stenosis, Atherosclerosis
- Keywords
- carotid, atherosclerosis, arteriosclerosis, plaque, neovascularization, carotid endarterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atherosclerosis is a systemic disease of the large arteries and the leading cause of death in Western society. The development of atherosclerosis involves the accumulation of lipids, cells and extracellular matrix in the blood vessel wall. It is a progressive disease characterized by the formation of a fibrous cap by smooth muscle cell proliferation and migration, and the development of a necrotic/lipid core. This core develops due to the accumulation of lipids and apoptosis of lipid-loaded macrophages. In this process the intima, the innermost layer of the blood vessel, thickens. This will lead to narrowing of the lumen and obstruction of blood flow. The developed lesion of the vessel wall may become vulnerable to rupture of the fibrous cap. Cap rupture exposes the necrotic core to the blood leading to the formation of a thrombus. The thrombus may fully or partially obstruct the lumen and cause cardiovascular complications, such as myocardial infarction or stroke. Although atherosclerosis forms the origin of most cardiovascular diseases, at present much remains unknown of the atherogenic process. Therefore, it is essential that research is done to discover novel mechanisms of atherosclerotic development. Intimal neovascularisation has recently drawn much attention as a novel factor, likely contributing to atherosclerotic plaque growth and rupture. Neovascularisation occurs when the intima thickens and is associated with stenosis, plaque inflammation and hemorrhage. Because increased amount of neovascularisation may be associated with increased risk for stroke, it would be highly desirable to identify plaque neovascularisation by noninvasive imaging. At present, imaging of neovascular development in atherosclerotic lesions with conventional ultrasound is not feasible, since the vessel diameter is well below the resolution capacity of currently available ultrasound systems. Since almost a decennium, contrast-enhanced ultrasound (CE-US) with gaseous ultrasound contrast agents has been used for research purposes but is now also widely commercially available and registered for clinical use, which can be done safely. With the help of such a gaseous contrast medium containing air bubbles smaller than erythrocytes (microbubbles) it might be possible to depict neovascularisation in a carotid artery plaque, due to the strong signal that will be evoked even by a small number of air bubbles as compared to the signal from the surrounding tissue. So, the intensity increase of the ultrasound signal from the carotid artery plaque after administration of microbubbles might reflect the amount of neovascularisation. Until now, only case reports concerning this technique have been published, especially no comparison with histology has been performed. So, 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. Magnetic resonance imaging (MRI) is well suited for evaluating carotid plaques; it is widely available, provides excellent soft tissue contrast, multiplanar imaging capability, and is free of ionising radiation. Multisequence MRI has shown to be able to detect different carotid plaque components in vivo. However, only very little experience exists in identifying neovascularisation by MRI. Also, newer MRI systems (>1.5 T), newer coil systems, and better pulse sequences have recently become available. Therefore, 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. Finally, 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: sulphur hexafluoride, gadopentate dimegluminePatients with symptomatic 70-99% carotid stenosis who are operated on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulphur hexafluoride, gadopentate dimeglumineCE-US, using 2 x 2.4 ml sulphur hexafluoride and MRI, using 1 x 0.2 ml/kg gadopentate dimeglumine | Drug | 1 |
Primary outcome
Plaque neovascularization at contrast-enhanced ultrasound and MRI
Time frame: Cross-sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner H Mess, MD, PhD principal investigator
Department of Clinical Neurophysiology, University Medical Center Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sulphur hexafluoride, gadopentate dimeglumine in people with Carotid Artery Stenosis and Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque neovascularization at contrast-enhanced ultrasound and MRI (time frame: Cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.