Clinical Trials

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13 studies in Division of Cardiovascular Diseases

  1. The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
    Rochester, Minn. View Summary

    The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the EndoPAT device. These same participants will also undergo a sleep study via the WATCHPAT device.

    NCT ID:

    NCT01500902

    IRB Number:

    09-000047

    Who can I contact for additional information about this study?

    Rochester: Rebecca E. Nelson, CCRC 507-255-8388
                        


  2. Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function
    Rochester, Minn. View Summary

    Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and cGMP pathway. The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and renal dysfunction will improve renal function with increased sodium excretion, glomerular filtration rate and effective renal plasma flow and renal function reserve as compared to the response of placebo-treated subjects.

    NCT ID:

    NCT01678794

    IRB Number:

    09-003284

    Who can I contact for additional information about this study?

    Rochester: Lynn Harstad 507-284-4838
                        


  3. Feasibility Testing of the Alert for Atrial Fibrillation Program
    Rochester, Minn. View Summary

    Feasibility Testing of the Alert for Atrial Fibrillation Program

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of the proposed research is to evaluate the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS), which is an instrument designed to tailor the delivery of the Alert for Atrial Fibrillation program. The proposed research will also test the feasibility of studying the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of AF in a larger, randomized trial. This research is significant, because current research suggests that treatment seeking for AF is hindered when people do not recognize symptoms that represent AF, attribute those symptoms to alternative causes, or do not believe symptoms are serious enough to require medical evaluation. Interventions tailored to modify patient-specific knowledge, attitudes, and beliefs that hinder early treatment-seeking are critically needed in order to improve early detection of AF. The long term goal of this research is to improve health outcomes of those at risk for developing AF.

    NCT ID:

    NCT01988974

    IRB Number:

    13-007768

    Who can I contact for additional information about this study?

    Rochester: Pamela McCabe, PhD, RN 507-293-1515
                        


  4. Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
    Rochester, Minn. View Summary

    Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.

    NCT ID:

    NCT00987415

    Who can I contact for additional information about this study?

    Rochester: Margaret Redfield, MD
                        


  5. Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
    Rochester, Minn. View Summary

    Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally growing and may be the most amendable to regenerative strategies. Therefore, identifying autologous cells (cells from the patient's own body) would be important to initiate these studies. This study aims to validate the use of umbilical cord blood as a source of autologous cells for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from the cord blood to help us determine the feasibility of collection, processing, and storage of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left heart syndrome. This study may be useful for the development of pre-clinical and clinical studies aimed at the long-term goal of repairing damaged heart muscle.

    NCT ID:

    NCT01856049

    IRB Number:

    11-007176

    Who can I contact for additional information about this study?

  6. Establishment of Normal Ranges for Newly Developed Cardiovascular Assays
    Rochester, Minn. View Summary

    Establishment of Normal Ranges for Newly Developed Cardiovascular Assays

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This research study is being done to determine levels of proteins that are normally present in the blood and urine of healthy individuals so as to compare to those levels in patients with heart disease.

    Normal blood and urine will be analyzed for levels of proteins and cardiac peptides which are affected by heart disease in the elderly. We are trying to determine if there are normal age-related changes when heart disease is not involved.

    IRB Number:

    718-05

    Who can I contact for additional information about this study?

    If you are interested in participating in this study or would like additional information, please contact Sharon Sandberg or Dr. Fernando Martin at (507) 284-4838.
  7. Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology
    Rochester, Minn. View Summary

    Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, MN that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

    NCT ID:

    NCT01527344

    IRB Number:

    11-003775

    Who can I contact for additional information about this study?

    Rochester: Rebecca E Nelson 507-288-8388
                        


  8. Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
    Rochester, Minn. View Summary

    Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.

    NCT ID:

    NCT01557842

    Who can I contact for additional information about this study?

    Rochester: Jasmine Sexton 507-293-1389
                        


  9. Biomarkers in Aortic Stenosis - B.A.S.S.
    Rochester, Minn., Jacksonville, Fla. View Summary

    Biomarkers in Aortic Stenosis - B.A.S.S.

    Location:

    Rochester, Minn., Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads who are referred for clinically-indicated echocardiographic exams at Mayo Clinic, in Jacksonville, Florida will be screened for participation in the study. The plan is to have 292 people take part in this study. This minimal risk study will consist of the recording of patient data, activity and bleeding questionnaires, and collection and analysis of blood samples.  Each blood sample will be analyzed for von Willebrand Factor antigen and activity, and von Willebrand Factor multimers, and BNP. Blood samples will be sent to the Mayo Special Coagulation Lab for analysis.

         Objective:

         This study seeks to assess the degree of association of the von Willebrand Factor activity indices and BNP to the severity of cardiac lesions, and to note a relationship between acquired bleeding the the hematologic abnormalities.  Plasma will be stored in attempt to develop new in vitro tests of von Willebrand factor (VWF) activity.

    NCT ID:

    NCT01334801

    IRB Number:

    09-006757

    Who can I contact for additional information about this study?

  10. Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
    Rochester, Minn. View Summary

    Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

    NCT ID:

    NCT00911508

    Who can I contact for additional information about this study?

    Rochester: HRS Research Office 507-255-7456
                        


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