Cardiovascular Medicine

Below are current clinical trials.

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

1. A Study of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction

   Jacksonville, Fla.

   The purpose of this study is to establish a registry that will address the data gap regarding the course of NSTEMI (Non-ST-Elevation Myocardial Infarction) between ED (Emergency Department) arrival and diagnostic angiography in detail, by characterizing and following the ED and peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED treatment patterns and success of both ischemic and bleeding risk stratification prior to definition of the coronary anatomy, data generated via the UPSTREAM registry will allow plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet therapy in the management of NSTEMI. This registry further seeks to demonstrate that contemporary use of upstream ticagrelor is associated with an economically-sound utilization of hospital resources, and smooth transition of care into the outpatient, secondary prevention setting for the first 30 days after hospitalization. Finally, it will allow characterization of patient selection factors and processes for ticagrelor vs alternative OAP agents, carrying out that descriptive comparison through discharge. Patients transferred in to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent administration and diagnostic catheterization begin with ED care at the first hospital.

2. Treating Breast Cancer Patients Undergoing Trastuzumab Treatment with Carvedilol to Reduce Incidence of Heart Failure

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.

    

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3. A Study to Develop A Familial Hypercholesterolemia Identification REgistry (FHIRE)

   Rochester, Minn.

   The purpose of this study is to develop a registry of molecularly confirmed Familial Hypercholesterolemia (FH) cases in conjunction with the retrospective FHIRE study (IRB# 18-009654) in order to identify and offer genetic testing to Mayo Clinic patients with suspected FH.

4. Ventricular Remodeling and Myocardial Deformation in Patients Undergoing Chemotherapy for Sarcomas

   Rochester, Minn.

   The aim of this study is to determine if there is subclinical systolic or diastolic myocardial mechanical dysfunction by 2D and 3D speckle tracking echocardiography derived strain and strain rate in this patient population at baseline, during and after chemotherapy. This could be an early marker  of myocardial dysfunction  in patients treated for sarcoma.

5. A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients

   Rochester, Minn.

   The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.

6. Patient-Specific Induced Pluripotent Stem Cell Models for Heritable Channelopathies and Cardiomyopathies

   Rochester, Minn.

   The purpose of this study is to derive and characterize patient-specific disease models for sudden death-predisposing heritable channelopathies and cardiomyopathies using iPS-cell technology.  It is hoped that the molecular, cellular, and electrophysiological phenotypes of these in-vitro disease models will further elucidate the pathophysiologic mechanisms underlying these sudden death-associated conditions.

7. Associated Anomalies with Right and Left Cusp Fusion Versus Right and Non-Coronary Cusp Fusion

   Rochester, Minn.

   The goal of this study is to determine whether significant differences exist in the prevalence of associated cardiac anomalies between right/left and right / non-coronary cusp fusion in bicuspid aortic valve.

8. Umbilical Cord Blood Collection and Processing for Severe Congenital Heart Disease

   Rochester, Minn.

   Congenital heart disease (CHD) is an abnormal formation that occurs during the development of a baby’s heart, heart valves and/or large vessels such as the aorta artery. CHD is the most common cause of major congenital defects accounting for almost 30% of all defects (Van der Linde D, JACC 2011). While the statistics vary among studies, the best birth prevalence estimate is 8 per 1000 live births (Bernier PL 2010). In the USA, CHD affects 1% of all births per year (Krasuki & Bashore 2016), with an estimated 40,000 babies born with any type of heart defect every year (Benjamin Emelia 2018).  Twenty-five percentof these are affected by a severe congenital heart defect (https://www.cdc.gov/ncbddd/heartdefects/data.html#References). Children with CHD who survive after the surgical procedures can develop heart failure and require a heart transplant at any time in their lives. Infants born with CHD need immediate medical attention and multiple follow-ups throughout their lives. Besides the social and economic impact of CHD on the individual and family lives, CHD treatment places a significant financial burden on the healthcare system. Simeone et al, (2014) reported that the cost of CHD hospitalization in the US was approximately $5.6 billion in 2019, accounting for 15.1% of the total cost for all pediatric hospitalizations in that year.

   The important improvements in CHD diagnosis and surgical treatment in the last decades has led to an increased survival of newborns affected with heart defects. A large number of CHD can be diagnosed during pregnancy, and the patients can present a broad range of symptoms. Forms of CHD are usually classified based on their severity, from mild to severe. One of the mildest forms of CHD is atrial septal defect, which can be undetectable until adulthood (Hoffman & Kaplan, 2002) and VSD (Penny DJ, 2011). On the other hand, severe CHD that requires multiple palliative surgeries includes single ventricle defects, such as hypoplastic left heart syndrome (HLHS) and tricuspid atresia.

   The survival of infants with CHD will depend on the severity of the defect and the time of diagnosis and treatment received. The one-year survival of newborns with severe or critical CHD (generally any type of surgery/procedures in their first year of life) is estimated to be 75%.

   Stem cell therapy has emerged as a new paradigm of treatment in the field of CHD with promising results. Cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with structural abnormalities may also be a good target for other research studies. In fact, the pediatric heart is naturally growing and may be amendable to regenerative strategies. Furthermore, the initial pre-clinical and clinical studies have demonstrated that the delivery of stem cells into the heart of patients with CHD is feasible and safe. Moreover, the cell therapy approach, along with the standard surgical palliation, seems to offer benefits over surgical treatment alone. Even though the number of cell therapy clinical trials for CHD has increased in the last decade, more long-term follow-up studies are needed in this population setting in order to define the role of stem cell therapy in the clinical practice. Therefore, confirming our ability to produce autologous cells (cells from the patient's own body) from patients with severe CHD is an important step towards the long-term goal of being able to discover innovative cell-based protocols.

9. A Study to Evaluate the Safety of Intracoronary Infusion of Extracellular Vesicles in Patients with Acute Myocardial Infarction

   Rochester, Minn.

   The purpose of this study is to determine the acute and long-term dose limiting toxicities of intracoronary infused PEP and the maximum tolerated dose in a cohort of coronary stent implantation patients.

10. The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

    Rochester, Minn.

    The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event.

    This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.