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Clinical Studies
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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II) (COSIRA-II)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.
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Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation
Rochester, Minn.
The purpose of this study is to evaluate the impact of interventions on important CV biomarkers to provide valuable information on the mechanism linking depression and anxiety to cardiac prognosis resulting in improved quality of life and diagnosis.
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Examination of the Impact of CalmiGo’s Stress Management Device on Vascular Health and Cardiovascular Disease Risk , and Markers of Mental Stress in Patients Following a Myocardial Infarction Participating in Clinically Indicated Cardiac Rehabilitation, patients who have had a recent coronary or structural intervention performed in the cardiac catheterization laboratory & patients being seen in the Mayo Clinic chest pain clinic for atypical chest pain (CalmiGo)
Rochester, Minn.
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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Is Our Microbiome a Predictor of Cardiac Risk?
Rochester, Minn.
The purpose of this study is to compare the fecal microbiota of patients with mild, moderate and severe Coronary Artery Disease (CAD) by collecting stool and blood samples from patients undergoing coronary angiograms.
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Tissue characteristics of early vascular aging
Rochester, Minn.
The purpose of this study is to investigate circulating and endothelial cell characteristics and mechanisms of early vascular aging in patients with early coronary artery disease.
Closed for Enrollment
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A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the
Efficacy and Safety of CLBS16 in Subjects with Coronary Microvascular Dysfunction and
Without Obstructive Coronary Artery Disease (CLBS16)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with coronary microvascular dysfunction (CMD) and without obstructive coronary artery disease
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A Phase 1, Feasibility Study Testing the Safety and Feasibility of Intracoronary CD34 Cell Administration on Coronary Endothelial Function in Patients With Early Coronary Atherosclerosis
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED).
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A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients with Coronary Microvascular Dysfunction
Rochester, Minn.
The purpose of this study is to evaluate the impact of the Neovasc Reducer™ device implantation on coronary microvascular function. It will be assessed invasively by measurement of coronary flow reserve (CFR) and the index of myocardial resistance (IMR) in patients with angina but no-obstructive coronary artery disease (ANOCA) and documented coronary microvascular dysfunction (CMD) [CFR ≤ 2.5 and/or IMR ≥ 25].
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A Randomized, Double-blind, Placebo-controlled Parallel Arm Dose Titration Study to Assess the Effects of SAR407899 in Patients With Microvascular Angina and/or Persistent Stable Angina Despite Angiographically Successful Elective Percutaneous Coronary Intervention (PCI)
Rochester, Minn.
The Primary Objective of this study: -To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow reserve (CFR) in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective percutaneous coronary intervention (PCI). The Secondary Objectives of this study are: - To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire physical limitation domain (SAQ-PL) in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective PCI. - To assess the safety of SAR407899 in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective PCI with a focus on identified risks such as hypotension and orthostatic hypotension. - To assess SAR407899 plasma concentrations in microvascular angina patients and/or persistent stable angina despite angiographically successful elective PCI.
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An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
Rochester, Minn.
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.
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Assessment of Coronary Plaque Composition Using Near Infrared Spectroscopy During Inhibition of LpPLA2 Activity
Rochester, Minn.
The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, our study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
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Cardiovascular Disease/ Pulmonary Hypertension and Voice Characteristics Study
Rochester, Minn.
The purpose of this study is to see if a new voice signal recording software program, can find a connection between abnormal voice signals and the presence and severity of cardiovascula disease / Pulmonary Hypertenison.
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Cardiovascular Disease/ Pulmonary Hypertension and Voice Characteristics Study (CVD/PH and VCS)
Rochester, Minn.
The purpose of this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN.
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Developing a Platform for Remote at Home Preoperative Evaluation for Obstructive Sleep Apnea
Rochester, Minn.
The purpose of this study is to demonstrate feasibility of obtaining at home remote pre-operative testing for obstructive sleep apnea prior to elective non-cardiac surgery. Additionally, to determine if obstructive sleep apnea can be screened for during a remote preoperative evaluation.
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Effects of Chardonnay Seed Flour on Vascular Health
Rochester, Minn.
This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).
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Effects of Hydroxytyrosol on Vascular Health
Rochester, Minn.
The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).
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Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans
Rochester, Minn.
The majority of the acute coronary events are caused by coronary artery segments with minimal luminal disease, but with potentially significant vascular wall inflammation and oxidative stress leading to plaque vulnerability. It has become apparent that an initial injury at the endothelial surface, is the primary site of the mechanisms involved and a role for vascular inflammation and the interaction with oxidative stress continues to emerge. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall inflammation that circulates in the blood bound to both low density (LDL) and high density (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and activity are an independent risk factor for cardiovascular events. Recent studies, demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction. However, the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary arteries, and the contribution of lipoprotein binding to the deleterious potential of Lp- PLA2 have not been elucidated. Our working hypothesis is that the endogenous local activation of the Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis and contributes to the mechanism of coronary endothelial dysfunction and the structural and mechanical properties reflecting plaque vulnerability. Thus, the current application will characterize prospectively the correlation between the functional, mechanical, and structural vascular wall properties, and the systemic as well as the coronary activity of the Lp-PLA2 pathway.
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Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans AIM III
Rochester, Minn.
AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB 08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac Catheterization Laboratory at Mayo Clinic in Rochester MN to be considered for this study.
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Pathogenesis and Mechanisms of Mitral Annular Calcification
Rochester, Minn.
The purpose of this study is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.
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Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients
Rochester, Minn.
The purpose of this study is to learn if there are predictive markers of hospitalization or death that can be found from data gathered from a Sleep Number® bed. This is a prospective observational cohort study that will follow participating subjects in the Masonic Homes/Acacia Creek Retirement Community in Union City, California.
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The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Rochester, Minn.
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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The Impact of Training with Whole Body EMS (EMS)
Rochester, Minn.
The purpose of this study is to assess the impact of training on peripheral endothelial function as measured using EndoPAT whole body-EMS for a 16-week period.
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