Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center

Criteria

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).