Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS

NCT01732523 | Recruiting

• 2 other identifiers: EK145/12PZ00P3_142419/1
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerosis is a chronic, systemic and progressive disease affecting different arterial blood vessels in the body. Atherosclerotic lesions silently progress from small plaques to severe stenosis and may remain asymptomatic for years. Unstable plaques and stenosis (also called vulnerable plaques), however, are prone to rupture leading to myocardial infarction, or stroke. The proliferation of the small arteries that are distributed to the outer and middle coats of the larger blood vessels (vasa vasorum) and within the atherosclerotic plaques (neovascularization) are inherently linked with the atherosclerotic plaque development, plaque inflammation and vulnerability. By injecting ultrasound contrast agents (microbubbles) into the blood stream, it is possible to detect this microcirculation of the vessel wall and the neovascularization within the atherosclerotic plaque using a contrast-enhanced ultrasound (CEUS) imaging technique. Particularly, CEUS of the carotid artery has been introduced as a non-invasive technique to improve detection of carotid atherosclerosis and to evaluate the presence of carotid plaque neovascularization which has emerged as a new marker for plaque vulnerability. The project investigates the predictive value of the detection of carotid plaque neovascularization on CEUS imaging in patients with asymptomatic carotid artery stenosis regarding the progression of the carotid atherosclerotic lesion and future vascular events including myocardial infarction, stroke or vascular intervention. The investigators hypothesize that neovascularization within the carotid lesion will significantly be more pronounced in patients with progressive carotid lesions and in patients suffering future vascular events during. The project will support the concept that intraplaque neovascularization is associated with plaque instability and vulnerability and therefore, the use of CEUS may provide an additional non-invasive, simple, safe, and reliable imaging modality to risk stratify individuals. The identification of vulnerable that are at increased risk of rupture by identification of intraplaque neovascularization is expected to improve the prediction of future vascular events and thus allow for better treatment selection. It will help the clinician to further risk stratify carotid stenosis. Particularly, it will help to identify unstable carotid stenosis that may already benefit from invasive therapy as carotid thromboendarterectomy and stenting.

Conditions

Carotid Stenosis

Keywords

Carotid stenosis; Vasa Vasorum; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Vascular event or vascular intervention

  The endpoint assessed will be the occurrence of any vascular event or vascular intervention. This composite end point includes any death of presumed vascular origin (fatal stroke, fatal myocardial infarction, sudden death, other vascular death), nonfatal stroke and TIA, nonfatal myocardial infarction, and any arterial vascular intervention that had not already been planned at the time of inclusion (eg, carotid surgery or angioplasty/stenting, coronary bypass, percutaneous coronary intervention, peripheral vascular surgery or angioplasty/stenting). All events and vascular interventions should be confirmed by hospital discharge report and medical files.

  10 years

Secondary Outcomes (1)

• Progression of carotid stenosis over time

  10 years

Study Arms (1)

No treatment

No intervention

Diagnostic Test: Contrast enhanced carotid ultrasound

Interventions

Contrast enhanced carotid ultrasound DIAGNOSTIC_TEST

No treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-and out-patients referred to our ultrasound laboratory for carotid ultrasound for a clinical indication (preoperative, carotid murmur, known carotid lesion) will be ask to participate in this clinical study and will be asked to undergo study carotid ultrasound including CEUS.

You may qualify if:

• Patients age \> 18 years
• Asymptomatic (no history of cerebrovascular event in the corresponding vessel territory) ≥30% carotid stenosis on standard carotid ultrasound

You may not qualify if:

• History of previous carotid endarterectomy or carotid stenting.
• Heart failure (HYHA III or IV)
• Myocardial infarction (\<7d)
• Severe pulmonal-arterial hypertension (pulmonal arterial pressure \>90mmHg) based on clinical information (history of pulmonal arterial pressure, dyspnea on exertion New York Heart Association (NYHA) III and NYHA IV)
• pregnancy (pregnancy test in patients of childbearing age: \<50 years and/or less than 2 years after menopause)
• Follow-up is not considered feasible

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Unversity Hospital Basel, Angiology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Staub, MD

  University Hospital Basle, Angiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Staub, MD

CONTACT

+41612655154; daniel.staub@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 26, 2012
• Study Start: October 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CH (1)