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There is a need to simplify the assessment of coronary and cerebral vascular networks in patients selected for carotid endarterectomy in order to prevent potential complications during and after surgery. A non-invasive, non-ionizing 3 dimension mapping of these networks would provide a remarkable benefit for patients.
Carotid atherosclerosis is associated with a high risk of stroke due to embolization from vulnerable plaques located at the carotid bifurcation. When the degree of stenosis exceeds 60%, carotid endarterectomy is considered to remove the plaque. This is a complex surgical procedure, performed under general anesthesia in most cases, and consists of extracting the plaque. The patient population is typically elderly and particularly fragile, with a significant risk of cerebral infarction during the intervention. To minimize perioperative risks, patients undergo a preoperative evaluation that includes transcranial Doppler ultrasound and coronary angiography. The purpose of transcranial Doppler is to image the circle of Willis and identify patients with an incomplete circle, which would compromise adequate cerebral perfusion during carotid clamping. However, this imaging is challenging because the quality of ultrasound through the skull is often poor, and two-dimensional imaging does not always allow full visualization of the circle of Willis. A high-resolution three-dimensional imaging modality could therefore improve surgical planning. Coronary angiography or CT coronary angiography are performed to image the coronary arteries and identify patients at highest risk of myocardial infarction. A non-ionizing three-dimensional imaging modality with high coronary resolution could also benefit patients by reducing radiation exposure.
Ten years ago, the Physics for Medicine Laboratory developed a novel imaging technique called ultrasound localization microscopy (ULM). This modality combines ultrafast ultrasound imaging (acquiring more than 1000 frames per second) with the injection of microbubbles already used in clinical practice. By individually imaging and localizing these microbubbles, it becomes possible to visualize the vascular networks of the coronary arteries and the brain in animal models with unprecedented resolution and field of view. Recently, the clinical feasibility of ultrasound localization microscopy was demonstrated in two dimensions in the brain of patients with cerebral aneurysms.
Nevertheless, the two-dimensional nature of the imaging represented a limitation. To address this, we developed a new type of wider ultrasound probe capable of imaging large three-dimensional volumes. These probes have already been validated through simulations, phantom studies, and more recently in animal experiments.
In this clinical study, we therefore aim to demonstrate the feasibility of three-dimensional imaging of the microcirculation of the heart and brain in patients during the preoperative evaluation, with the goal of improving surgical planning for carotid endarterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound localization microscopy | Experimental | The research protocol is integrated into the patient's routine preoperative visit. During this visit, the patient undergoes echocardiography and Doppler ultrasound of the supra-aortic trunks combined with transcranial Doppler. The use of microbubbles (SonoVue®) as a contrast agent is common in cases of poor visualization. We propose to add dedicated ultrasound localization microscopy sequences coupled with SonoVue® injection during this examination in order to image the circle of Willis and the coronary arteries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound localization microscopy, circle of Willis | Device | Ultrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting the presence of an incomplete circle of Willis | Detection of all arteries of the circle of Willis using ultrasound localization microscopy, compared with cerebral Computed Tomography angiography or Magnetic Resonance Imaging, routinely performed before carotid endarterectomy. | At day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting the presence of coronary stenosis | Detection of coronary stenosis using ultrasound localization microscopy, compared with coronary Computed Tomography angiography or coronary angiography, routinely performed before carotid endarterectomy. | At day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tessa BERGOT, MSc | Contact | +33 1 44 90 70 33 | tessa.bergot@sfcardio.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume GOUDOT, MD | APHP, Georges Pompidou European Hospital, France | Study Chair |
| Clément PAPADACCI, PhD | Institut National de la Santé Et de la Recherche Médicale, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georges Pompidou European Hospital | Paris | 75015 | France |
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Exploratory investigation, first in human, one center, open study,
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| Ultrasound localization microscopy, coronary arteries | Device | ultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy |
|
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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