Clinical Trials

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45 studies in Division of Cardiovascular Diseases

  1. A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure
    Rochester, Minn. View Summary

    A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy).

    NCT ID:

    NCT01966458

    IRB Number:

    13-006972

    Who can I contact for additional information about this study?

    Rochester: Cathy Anderson Severson 507-255-2673
                        


  2. 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
                        


  3. Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome
    Rochester, Minn. View Summary

    Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is a Phase I trial to determine the safety of autologous mononuclear cells (MNC) derived from umbilical cord blood for intramyocardial delivery into the right ventricle during a planned and non-emergent Stage II surgical palliation in subjects with HLHS. This is the first critical step towards applying autologous MNC therapy as an add-on regenerative intervention for congenital heart disease management. The choice of HLHS as the target disease for regenerative therapies in congenital heart disease management is multi-factorial and includes the following considerations: 1) Severity of of this incurable disease, 2) palliative nature and burden of long-term outcomes with a single right ventricular system, 3) three stages of planned surgical procedures that provide time points to adjunctively intervene, and 4) prenatal diagnosis enabling planned collection of UCB. An emerging goal for cardiac regeneration includes the application of cell-based technology to congenital heart disease, which is a favorable substrate due to the lack of fibrotic scaring, and the presence of a microenvironment that is expected to support ongoing cardiac proliferation and growth for functional remuscularization. This Phase I safety study will determine the feasibility of collection, processing, and delivery of autologous cells as used in adult cardiac regenerative protocols in the setting of HLHS surgical management.

    NCT ID:

    NCT01883076

    IRB Number:

    12-008521

    Who can I contact for additional information about this study?

    Rochester: Julia Thebiay 507-538-8425
                        


  4. 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
                        


  5. Clinical Trials - Mayo Clinic Research
    Rochester, Minn. View Summary

    Clinical Trials - Mayo Clinic Research

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is being done to better understand how genetic information might improve assessment of heart attack risk.


    NCT ID:

    NCT01936675

    IRB Number:

    12-001727

    Who can I contact for additional information about this study?

  6. The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
    Rochester, Minn. View Summary

    The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision. This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.

    NCT ID:

    NCT01771536

    IRB Number:

    12-004554

    Who can I contact for additional information about this study?

  7. Drug Therapy for the Treatment of Anemic Patients with Congestive Heart Failure
    Rochester, Minn. View Summary

    Drug Therapy for the Treatment of Anemic Patients with Congestive Heart Failure

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This research study is being done to see if the investigational use of the drug darbepoetin alfa, which is given to treat anemia (low number of red blood cells), will have an effect on your ability to exercise on a treadmill and on your clinical symptoms.  Previous observations in a small number of patients suggests that improved blood counts may improve these symptoms.

    IRB Number:

    1049-02

    Who can I contact for additional information about this study?

      Dr. Barry L. Karon
      Study Coordinator: Annette McNallan, RN (507) 266-3639 or pager 127-07890
  8. Ventricular Remodeling and Heart Failure After Myocardial Infarction: A Community Study
    Rochester, Minn. View Summary

    Ventricular Remodeling and Heart Failure After Myocardial Infarction: A Community Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction (MI) in the community, study the association between patterns of remodeling and biological pathways and examine the association between the predictors of remodeling and heart failure after Myocardial Infarction.

    NCT ID:

    NCT02047396

    IRB Number:

    13-009187

    Who can I contact for additional information about this study?

    Rochester: Ellen E Koepsell, RN 507-538-0047
                        


  9. Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI
    Rochester, Minn. View Summary

    Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI. The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair. Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites. The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis: H0+: true mean % difference > 10% and H0-: true mean % difference < -10% The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.

    NCT ID:

    NCT01419756

    IRB Number:

    12-003920

    Who can I contact for additional information about this study?

    Rochester: Benjamin Eidem, MD
                        


  10. Personality Profile of Patients With Apical Ballooning Syndrome (ABS)
    Rochester, Minn. View Summary

    Personality Profile of Patients With Apical Ballooning Syndrome (ABS)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.

    NCT ID:

    NCT01885975

    IRB Number:

    13-003419

    Who can I contact for additional information about this study?

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