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A Study to Identify Risk Factors from any Reason for Hospital Readmission, Death, or Declining Health in Older Persons who were Hospitalized with a Heart Attack
Rochester, MN
The purpose of this study is to gather data to develop a risk model that can be used to help doctors predict the recovery of older persons who have been admitted to the hospital with a heart attack. Information will be collected on hospital readmissions, death, and decline in health from any cause following a heart attack. The goal is help older people in the future make well-informed decisions about their health care during a heart attack.
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A Study of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction
Jacksonville, FL
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 ...
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Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk (CalmiGo)
Rochester, MN
The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.
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A Study to Evaluate the Safety of Intracoronary Infusion of Extracellular Vesicles in Patients with Acute Myocardial Infarction
Rochester, MN
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.
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A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Scottsdale/Phoenix, AZ
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
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Early Coronary Angiography Versus Delayed Coronary Angiography
Rochester, MN
This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories ...
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Application for Self-Monitoring of Cardiovascular Risk
Rochester, MN
Patients who recently suffered a heart attack will use a smart-phone/computer application during cardiac rehabilitation to reduce their risk of a future attack, their re-hospitalizations, their cost of care, and increase their quality of life.
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Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction
Rochester, MN
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).
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Cardiac MRE In Acute Myocardial Infarction
Rochester, MN
We have recently developed a new and novel imaging-based technique known as cardiac Magnetic Resonance Elastography (MRE) that is capable of differentiating differing regions of myocardial stiffness in the myocardium. The condition which myocardial stiffness has been most studied and is thought to vary the most from normal is myocardial infarction. Cardiac MRE findings in acute infarction have not been established and the prognostic significance of cardiac MRE-defined infarct stiffness are unknown. The aims of this study are to compare cardiac MRE stiffness to microvascular obstruction in acute myocardial infarction, to determine the association of cardiac MRE infarct stiffness with left ventricular ...
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Micra Transcatheter Pacing Study
Rochester, MN
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
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Serological Strategy to Optimize Prognostic Stratification in Myocardial Infarction
Rochester, MN
Identify novel molecular targets associating clinical findings with ‘omics outputs to create a serum-based approach prognostic of patient baseline MI propensity at the time of MI-related injury
Identify novel molecular targets associating clinical findings with ‘omics outputs to create a serum-based approach prognostic of heart failure vulnerability at the time of MI-related injury
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A Study to Evaluate Cardiac Magnetic Resonance Elastrography (MRE) of Acute Myocardial Infarcts
Rochester, MN
The purpose of this study is to determine whether cardiac magnetic resonance elastography (MRE) can detect acute myocardial infarctions in humans as areas of increased stiffness, and to compare cardiac MRE stiffness to microvascular obstruction in acute myocardial infarction.
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Home Telemonitoring In Patients After Myocardial Infarction
Rochester, MN
The purpose of this study is to evaluate patients undergoing cardiac catheterization. The hypothesis is that patients who go home with 12 lead ECG home telemonitoring will have decreased general and cardiac ED presentation and hospital readmission rates without an increase in major adverse cardiac events and at a lower health care utilization cost compared to patients with standard therapy alone.
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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Scottsdale/Phoenix, AZ
The primary objective of the study is to assess the clinical effectiveness of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.
The secondary objective is to assess the safety of self-administration of selatogrel.
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Shockless IMPLant Evaluation in Replacements
Rochester, MN
The purpose of this study is to demonstrate the event rate of the primary outcome, defined as failure of DFT at a single shock at 10 Joules below maximal capacity of the device.
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A Study to Evaluate Autologous Bone Marrow Mononuclear Cells Using the CardiAMP™ Cell Therapy in Patients With Post Myocardial Infarction Heart Failure
Scottsdale/Phoenix, AZ
The purpose of this study is to compare treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects will precede the randomised phase.
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Myocardial Infarction Genes (MI-GENES) Study
Rochester, MN
This study is being done to better understand how genetic information might improve assessment of heart attack risk.
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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Rochester, MN
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.
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A Study for the Continued Access of the Micra Transcatheter Pacing System
Rochester, MN
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
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Ventricular Remodeling and Heart Failure after Myocardial Infarction: A Community Study
Rochester, MN
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.
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A Study to Assess Beta-Blocker Use in Patients with Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction
Rochester, MN
The purpose of this study is to determine the prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) and to characterize the phenotypic expression and severity of their underlying lung disease. Also to determine the association between beta-blocker use at discharge and cardiopulmonary outcomes in patients with COPD and AMI.
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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Scottsdale/Phoenix, AZ
The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.
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ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Rochester, MN
The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
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Myocardial Ischemia and Transfusion
Rochester, MN
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
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A Study of Biomarkers for Human Heart Failure
Rochester, MN
The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction).
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Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Rochester, MN
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.
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CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
Rochester, MN
The primary endpoint is to assess the safety and tolerability of CD-NP with the incidence of symptomatic hypotension being one of the key safety variables.
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Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Scottsdale/Phoenix, AZ
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
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A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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A Study to Evaluate DDP3 as a Predictor of Cardiogenic Shock in Patients Presenting with Cardiac Symptoms
Rochester, MN
The purpose of this study is to evaluate whether DDP3 identifies patients at early risk of cardiogenic shock presenting with STEMI in order to benefit from more aggressive cardiology scrutiny.
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A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation
Rochester, MN
The main purpose of the study is to examine the effect of two different high intensity interval training (HIIT) prescription approaches on improving fitness, heart function, and the ability of the body's muscles to receive oxygen. The two approaches of the same total exercise durston will include: 1) HIIT with progressively increased interval durations (PRO-HIIT) versus 2) HIIT with constant shorter interval durations (CON-HIIT). The study hypothesis is that the progressively increased interval duration at high-intensity (PRO-HIIT) will result in a greater increases in fitness, heart function, and the ability of the body's muscles to receive oxygen in patients enrolled in cardiac rehabilitation.
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A Study to Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
Rochester, MN
The purpose of this study is to measure overall activity (sedentary-to-high intensity) during rehab and at 1 year follow-up.
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Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Rochester, MN
The purpose of this study is to evaluate comparisons between a hybrid program of center-based CR which incorporates mHealth remote case management technology (CON+) to a traditional center-based program alone (CON) as well as comparisons between home-based mHealth remote case management alone (HOM+) to a traditional center-based program (CON).
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A Study to Investigate Outcomes and Management Effectiveness of Cardiogenic Shock II Patients
Rochester, MN
The purpose of this study is to develop a registry of patients with clinical cardiogenic shock (CS) in order to allow better definition of several key issues regarding cardiogenic shock.
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Virtual World-based Cardiac Rehabilitation Program to Encourage Healthy Lifestyle Choices Among Cardiac Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to assess the feasibility and utility of a virtual world-based cardiac rehabilitation (CR) program as an extension of a face-to-face conventional CR program (Destination Rehab).
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A Study of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea to Prevent Cardiovascular Disease
Rochester, MN
Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep and is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure ...
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A Study Comparing Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valve Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.
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Spontaneous Coronary Artery Dissection (SCAD):Utility of Echocardiography including Contrast and Strain Imaging
Rochester, MN
The purpose of this study is to perform and analyze standard transthoracic echocardiography with contrast and strain imaging in 80 consecutive patients seen in the Mayo Clinic Spontaneous Coronary Artery Dissection (SCAD) Clinic and interpret any prior pre- or post-SCAD echocardiogram studies for comparison.
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TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)
Jacksonville, FL
The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.
Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years)
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A Study to Create and Maintain Plasma and Serum Bank for Patients with Thrombosis
Rochester, MN
The purpose of this study is to create and maintain a clinical database of patients with history of, or who are at high risk for thromboembolic diseases, along with a plasma/serum repository. We plan to evaluate novel biomarkers that might be associated with thromboembolic diseases and test whether these biomarkers will help predict the incident and recurrentrecurrences of thromboembolic episodes and other outcomes (e.g., mortality, post thrombotic syndrome).
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A Study to Analyze Association of Frequent Premature Ventricular Complex with Stroke or Transient Ischemic Attack
Rochester, MN
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.
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A Study to Evaluate Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation
Rochester, MN
The objectives of this study are to examine the prevalence of comorbid sleep disordered breathing (SDB) and insomnia in post-MI patients enrolled in cardiac rehabilitation (CR), to assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without, and to determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR than those without.