Cardiovascular Diseases and Cardiac Surgery

Below are current clinical trials.

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1. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

2. Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

   Rochester, Minn.

   The purpose of this study is to determine and compare the safety and efficacy of transcutaneous afferent patterned stimulation (TAPS) and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) therapies for the reduction of paroxysmal atrial fibrillation (AF) burden.

3. Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD

   Rochester, Minn.

   The purpose of this study is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients.

    

4. A Study of the Effect of Myectomy on the Sudden Cardiac Death Risk in Hypertrophic Cardiomyopathy

   Rochester, Minn.

   The primary purpose/objective of this study is to determine whether myectomy as a management option for severe hypertrophic cardiomyopathy (HCM) reduces the incidence of sudden cardiac death.

5. Prospective Identification of Long QT Syndrome in Fetal Life

   Rochester, Minn.

   The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and undiagnosed during fetal life, with dire consequences. For example, maternal medications commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal ventricular arrhythmias. But the most significant consequence is the missed opportunity for primary prevention of life threatening ventricular arrhythmias after birth because the infant is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS. Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses recruited from 13 national and international centers where one parent is known by prior genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2 (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have chosen this population because 1) These mutations are the most common genetic causes of LQTS, and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of having the same parental LQTS mutation. The algorithm will be developed using FHR measured serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the parental mutation as the gold standard for diagnosing the presence or absence of LQTS.

6. A Study to Evaluate the Burden of Treatment and Illness in Advanced Heart Failure Patients

   Rochester, Minn.

   The primary purpose of this study is to identify which aspects of treatment are most prevalent and burdensome to patients with advanced heart failure.

7. Invasive and Noninvasive Assessments of Myocardial Elasticity

   Rochester, Minn.

   The purpose of this study is to assess the correlation between myocardial elasticity (ME) measurements obtained simultaneously during cardiac hemodynamic catheterization and intraprocedural echocardiography.

8. Spontaneous Coronary Artery Dissection: Mechanistic Evaluation

   Rochester, Minn.

   The purpose of this study is to screen for unique or characteristic circulating peptides, hormonal biomarkers and circulating mRNA in patients who have experienced spontaneous coronary artery dissection (SCAD).

    

9. Study of Awareness and Detection of Familial Hypercholesterolemia (CASCADE-FH)

   Rochester, Minn.

   The CASCADE Familial Hypercholesterolemia Registry will track therapy, clinical outcomes, and patient-reported outcomes over time aiming to increase familial hypercholesterolemia awareness, promote optimal disease management, and improve outcomes. This study is not recruiting family members of FH patients at this time.

10. A Study to Analyze Association of Frequent Premature Ventricular Complex with Stroke or Transient Ischemic Attack

    Rochester, Minn.

    The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.