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Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01732523
First received: November 16, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition
Carotid Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Carotid Lesion Neovascularization Detected by Contrast-enhanced Ultrasound (CEUS) in Patients With Asymptomatic Carotid Stenosis

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Vascular event or vascular intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression of carotid stenosis over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    progression of carotid stenosis over time (progression in the lesion area, lesion volume, and degree of stenosis) assessed by yearly repeated standard carotid ultrasound study. Based on the yearly repeated standard carotid ultrasound studies progression rate of the lesion area and the lesion volume can be quantified for each stenosis and specify as continuous variable in cm2/year (area progression/year) and in cm3/year (volume progression/year). Additionally, the progression of the grade of stenosis will be quantified as categorical variable by determining the change of the stenosis category over time (30-49%, 50-69%, 70-99%, 100%) (Stable stenosis or increase in 1, 2, or 3 categories over 5 years).


Estimated Enrollment: 240
Study Start Date: October 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732523

Contacts
Contact: Daniel Staub, MD +41612655154 staubd@uhbs.ch

Locations
Switzerland
Unviversity Hospital Basle, Angiology Recruiting
Basle, Switzerland, 4031
Contact: Daniel Staub, MD    +41612655154    staubd@uhbs.ch   
Principal Investigator: Daniel Staub, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Daniel Staub, MD University Hospital Basle, Angiology
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01732523     History of Changes
Other Study ID Numbers: EK145/12, PZ00P3_142419/1
Study First Received: November 16, 2012
Last Updated: January 16, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Carotid stenosis
Vasa Vasorum
Ultrasonography

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Neovascularization, Pathologic
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Metaplasia
Nervous System Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014