- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01732523
Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS
March 22, 2024 updated by: University Hospital, Basel, Switzerland
Predictive Value of Carotid Lesion Neovascularization Detected by Contrast-enhanced Ultrasound (CEUS) in Patients With Asymptomatic Carotid Stenosis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel Staub, MD
- Phone Number: +41612655154
- Email: daniel.staub@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Unversity Hospital Basel, Angiology
-
Contact:
- Daniel Staub, MD
- Phone Number: +41612655154
- Email: daniel.staub@usb.ch
-
Principal Investigator:
- Daniel Staub, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No treatment
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular event or vascular intervention
Time Frame: 10 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of carotid stenosis over time
Time Frame: 10 years
|
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).
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel Staub, MD, University Hospital Basle, Angiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2012
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
November 16, 2012
First Submitted That Met QC Criteria
November 23, 2012
First Posted (Estimated)
November 26, 2012
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Carotid Artery Diseases
- Metaplasia
- Carotid Stenosis
- Neovascularization, Pathologic
- Constriction, Pathologic
Other Study ID Numbers
- EK145/12
- PZ00P3_142419/1 (Other Grant/Funding Number: Swiss National Science Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carotid Stenosis
-
Heinrich-Heine University, DuesseldorfRecruitingCarotid Artery Plaque | Carotid Artery Diseases | Carotid Artery Stenosis Asymptomatic | Carotid Artery StenosisGermany
-
Xuanwu Hospital, BeijingChanghai Hospital; Peking Union Medical College Hospital; The Second Hospital... and other collaboratorsRecruitingCarotid Artery Stenting | Carotid Endarterectomy | Best Medical Treatment | Carotid Artery Stenosis AsymptomaticChina
-
Xuanwu Hospital, BeijingRecruitingRadiation-induced Carotid Artery StenosisChina
-
Centre Hospitalier St AnneHôpitaux Universitaires Paris Ile-de-Franc OuestNot yet recruiting
-
Ochsner Health SystemWithdrawnTCD | Symptomatic Carotid Stenosis | Asymptomatic Carotid Stenosis | HITSUnited States
-
University of BolognaActive, not recruiting
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); Cedars-Sinai Medical Center and other collaboratorsRecruitingCarotid Atherosclerosis | Asymptomatic Carotid Artery Stenosis | Carotid Artery AtheromaUnited States
-
Mayo ClinicRecruitingPatients With Any Degree of Carotid Artery Stenosis and Vulnerable Features in the Carotid Artery PlaqueUnited States
-
W.L.Gore & AssociatesCompleted
-
Tang-Du HospitalRecruitingPostoperative Risk Factors for Patients With Carotid Artery StenosisChina
Clinical Trials on Contrast enhanced carotid ultrasound
-
Ospedale San Giovanni BellinzonaCompletedCarotid Artery Disease | Plaque NeovascularizationSwitzerland
-
Dr. Amer JohriLantheus Medical ImagingRecruitingMyocardial Infarction | Cardiovascular Diseases | Atherosclerosis | Carotid Artery Diseases | Acute Coronary Syndrome | Ischemic Heart DiseaseCanada
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI); University of California, San Diego; GE Healthcare and other collaboratorsCompletedHepatocellular Carcinoma | Chemoembolization, TherapeuticUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
University of Southern CaliforniaWithdrawnAbdominal Aortic AneurysmUnited States
-
University Hospital FreiburgWithdrawn
-
University Hospital, ToursUnknown
-
University Hospital, ToursCompleted
-
Mayo ClinicCompletedTransplantation, KidneyUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingThyroid Carcinoma | Thyroid NoduleChina