Coronary artery disease

Displaying 32 studies

  • Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions Rochester, MN

    The purpose of this registry is to collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.

  • A Study to Evaluate Ischemia in Women to Reduce Non-obstructive CAD Events Jacksonville, FL

    The purpose of this trial is to determine whether aggressive medication treatment to modify risk factors in women with coronary arteries showing no severe obstruction but with cardiac symptoms (i.e., chest pain) will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. 

  • Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device Rochester, MN

    The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

  • Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry Rochester, MN

    The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort design to follow patients who have multivessel or left main coronary artery disease ("surgical anatomy" according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be selected to participate in the registry from a national network of leading centers across the United States with recognized expertise in both complex PCI and coronary artery bypass surgery. We will invite leading cardiac centers, as defined by US News and World reports rankings for heart care. ...

  • An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery Jacksonville, FL

    The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.

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

    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 ...

  • A Study of the Effectiveness and Safety of Targeted Delivery of Auto CD34+ Stem Cells into Heart Muscle for Improving Exercise Capacity in People with Angina Resistant to Treatment Scottsdale/Phoenix, AZ

    The purpose of the study is to assess the safety and effectiveness of targeted delivery of Auto-CD34+ stem cells into heart muscle tissue to increase exercise time and decrease anginal symptoms in patients who have angina resistant to treatment and chronic heart muscle death.

  • A Study to Evaluate the Effect of Metformin on Frailty in 12 Subjects (6 Metformin/6 Placebo in a Randomized Fashion) Rochester, MN

    The purpose of this study is to test whether chronic metformin administration will improve longevity of the cell, improve its machinery by reducing aging-related biochemical parameters, and improve physical performance as measured by short physical performance battery test.

  • A Study Relating Voice Characteristics and Coronary Artery Disease Rochester, MN

    The purpose of this study is to see if a new voice signal recording software program, called Beyond Clinical, can find a connection between abnormal voice signals and the presence and severity of coronary artery disease.

  • Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases Rochester, MN

    This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the performance of the CADence device in detecting the existence of clinically significant coronary artery disease.

  • Is Our Microbiome a Predictor of Cardiac Risk Rochester, MN

    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.

     

  • Olive Oil and Cardiovascular Health Rochester, MN

    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).

  • Hypertensive Pregnancy Disorders and Future Coronary Artery Disease Rochester, MN

    The purpose of the study is to determine if:

    • A history of hypertensive pregnancy disorders (HPD), in general, and preeclampsia, in particular, compared to normotensive pregnancies, confers an increased risk for coronary artery disease (CAD) after controlling for traditional risk factors.
    • A history of HPD, in general, and preeclampsia, in particular, compared to normotensive pregnancies, is associated with more severe atherosclerotic disease at the time of the diagnosis of CAD.
    • A history of HPD, in general, and preeclampsia, in particular, compared to normotensive pregnancies, increases the risk for a composite outcome of subsequent CAD, atrial fibrillation, ...

  • The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry Rochester, MN

    The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event.

    This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

  • Exercise and Low-Dose Rapamycin in Older Adults with CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial Albert Lea, MN; Austin, MN; Rochester, MN

    The investigators will do the study in two phases. The first phase will be a pilot study on up to 18 participants [patients 60 years or older with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the duration of CR. Baseline and follow-up data will be collected for age-associated impairment (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory phenotype (SASP)and abdominal/thigh ...

  • ISCHEMIA-Chronic Kidney Disease Trial Rochester, MN

    The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and ...

  • ABSORB III Randomized Controlled Trial (RCT) Rochester, MN

    The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

    The ABSORB III includes additional two trials i.e. ABSORB III PK sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

  • Determining the Natural and "Unnatural" History of Anomalous Aortic Origin of a Coronary Artery with an Interarterial or Intraconal or Intermural Course (AAOCA): Establishing a Multi-Institutional Registry Rochester, MN

    The purpose of the study is to determine the outcome of surgical intervention versus observation in children and young adults with AAOCA. To do this the plan is to create a registry of AAOCA subjects that will enable us to develop a risk stratification model utilizing a large multi-institutional registry under the auspices of the Congenital Heart Surgeons’ Society (CHSS).

  • OPTIMIZE IDE for the Treatment of ACS Rochester, MN

    Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm

  • Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Rochester, MN

    ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with ...

  • A Study to Evaluate Cardiopulmonary Exercise Testing in Liver Transplant Candidates Scottsdale/Phoenix, AZ

    The purpose of this study is to determine agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC) for the identification of subclinical coronary artery disease in liver transplant candidates, to determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) for the identification of cirrhotic cardiomyopathy in liver transplant candidates, and to determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test (SOC), for the identification of frailty in liver transplant candidates.

  • Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults La Crosse, WI; Rochester, MN

    A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.

  • International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) Rochester, MN

    The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

    SPECIFIC AIMS

    A. Primary Aim

    The primary aim of the ISCHEMIA trial is to ...

  • A Study to See if MPI SPECT Phase Analysis Can Detect Varying Levels of Changes in Heart Rhythm Patterns Rochester, MN

    The purpose of this study is to determine if MPI SPECT phase analysis can detect varying degrees of abnormal heart rhythm between patients with normal coronary artery circulation, ischemia (poor blood circulation), and infarct (area of dead tissue) from loss of circulation.

  • VEST Venous Graft External Support Pivotal Study Rochester, MN

    Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.

  • New Technologies to Determine Carotid Plaque Vulnerability Rochester, MN

    Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices).

    Primary Aims:

    1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for detection of carotid plaque:

      • To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle tracking strain imaging SE .
      • To determine if carotid CEUS and two-dimensional speckle tracking strain imaging findings are associated with coronary angiographic results in those patients undergoing clinically indicated cardiac catheterization.
      • To determine the diagnostic accuracy of ...

  • A Study to Compare the Effectiveness of Invasive versus Conservative Medical Approaches in Patients with Stable Ischemic Heart Disease and Advanced Chronic Kidney Disease Scottsdale/Phoenix, AZ

    The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and ...

  • 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.

  • Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol Rochester, MN

    This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

  • Spontaneous Coronary Artery Dissection: Case Review Rochester, MN

    Spontaneous coronary artery dissection (SCAD) is uncommon but important cause of acute coronary syndrome and sudden cardiac death. There is very little data exists in regards to patient clinical characteristics, risk factors, treatment and outcomes. Our objective is to prospectively assess long term outcomes. 

  • A Repository of Atria Tissue for the Investigation of Atrial Pathophysiology in Patients with Atrial Fibrillation Rochester, MN

    The purpose of this study is to collect surgically removed atrial tissue for genetic, pathologic, metabolic, and molecular studies in patients with or without a history of atrial fibrillation.

  • Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease Rochester, MN

    The researchers are trying to see whether contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography improves arterial wall visualization and identifies arterial elastic properties among individuals with fibromuscular dysplasia (FMD), atherosclerosis, personal history of spontaneous coronary artery dissections (SCAD), or personal history of segmental arterial mediolysis (SAM) that may be different compared to those without the aforementioned conditions.

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