Cardiovascular Diseases and Cardiac Surgery

Below are current clinical trials.

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

1. 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.

2. A Study to Develop a Pulmonary Hypertension Association Registry (PHAR)

   Rochester, Minn.

   The primary purpose of this study is to measure and improve quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes).

3. 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.

4. 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.

5. A Study of Arrhythmia in Eisenmenger’s Syndrome

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to describe the incidence and type of arrhythmia seen in patients with Eisenmenger syndrome, to define predisposing factors potentially leading to the onset of arrhythmia, and to describe the influence of arrhythmia on outcomes.

6. A Study to Evaluate Potential Myocardial Injury Following Elective Direct Current Cardioversion

   Rochester, Minn.

   The purpose of this study is to prospectively determine if direct current cardioversion (DCCV) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT) assay.

7. International Triadin Knockout Syndrome Registry

   Rochester, Minn.

   The aim of this study is to determine the worldwide prevalence of Triadin Knockout Syndrome (TKOS), and to better define the phenotype of patients with the disease. This information will provide additional insight into which phenotypic markers may be specific to TKOS, and will also help to develop better TKOS specific treatment strategies.

8. A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium

   Rochester, Minn.

   The purpose of this study is to evaluate the effect of a pre-ICU admission simulation session on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.

    

    

    

9. Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

   Rochester, Minn.

   The primary purpose of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in WHO functional class.

10. Global Cardio Oncology Registry

    Rochester, Minn.

    The purpose of this study is to provide a large database and platform for prospective sub-studies and eventually develop additional collaborations with a platform for clinical studies and trials following the initial pilot phase.