Vascular Centers

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study of Patients Who Underwent Intravascular Ultrasound to Create a Registry

   Rochester, Minn.

   Since Intravascular Ultrasound (IVUS) emerged as a significant tool for detection of early coronary atherosclerosis, we are maintaining an ongoing registry of those patients who have had this procedure done to provide more information regardint the successful interpretation of these intravascular ultrasound (IVUS). 

2. A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

   Jacksonville, Fla.

   The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

3. Study to Validate the Use of Hand-Held Mobile 3D Scanning to Obtain Volumetric Measurements for Staging Disease Severity in Lymphedema Patients

   Jacksonville, Fla.

   The purpose of this study is to validate the use of LymphaTech's Hand-Held Mobile 3D Scanning to obtain volumetric measurements in order to stage disease severity in patients diagnosed with lymphedema, and also serve as an imaging biomarker for microsurgical treatment response.

4. IPSS Consortium Study

   Rochester, Minn.

   The overall objective of our network of investigators is to develop and conduct clinical trials and other large multi-centre studies in childhood stroke. Our specific aims are:

   Objective 1: To ascertain in a prospective, consecutive cohort study the numbers of newborns and children with ischemic stroke, their stroke sub-types and risk factors, their current treatments and outcomes within our centers. These data will provide the rationale and feasibility data for our group to design and implement the initial randomized controlled trials (RCTs) in paediatric stroke as well as other fundable grant proposals.

   Objective 2: To develop standardized data collection forms and an appropriate database with web-based data entry from multiple study sites.

   Objective 3: To develop standardized protocols for (1) diagnosis, (2) investigation of risk factors, (3) outcome assessment and 4) antithrombotic therapies of neonates and children with arterial ischemic stroke (AIS) and cerebral sinovenous thrombosis (CSVT)

   Objective 4: Obtain grant funding to support and conduct additional multi-centre IPSS sub-studies

5. A Study Testing the Effectiveness and Safety of KPL-301 in Patients with Giant Cell Arteritis

   Rochester, Minn.

   The primary purpose of this study is to evaluate the effectiveness and safety of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

6. A Study Determining Disease Activity Biomarkers in Individuals with Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss) Syndrome

   Rochester, Minn.

   Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with EGPA.

7. Study of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients

   Jacksonville, Fla.

   The purpose of this study is to evaluate the effectiveness and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.

8. Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

   Rochester, Minn.

   The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.

   Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis.

9. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

   Jacksonville, Fla., Rochester, Minn.

   We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

10. International Bicuspid Aortic Valve Consortium (BAVCon)

    Rochester, Minn.

    Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

    The Specific Aims of this study are:

    1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.

    2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

    To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.