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Study Title Principal Investigator
ST Monitoring to Detect ACS Events in ICD Patients
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.
Active, not recruiting | Atherosclerosis | Multisite
Michael Gibson
Nattokinase Atherothrombotic Prevention Study
Objectives and Hypotheses: The goal of the proposed study is to determine under randomized controlled trial (RCT) conditions whether nattokinase reduces subclinical atherosclerosis and cognitive decline in healthy women and men. The investigators' hypotheses are: 1) Compared to placebo, nattokinase will show less subclinical atherosclerosis progression and cognitive decline in healthy women and men; 2) The reduction in subclinical atherosclerosis progression and cognitive decline with nattokinase will be correlated; and, 3) The reduction in progression of subclinical atherosclerosis and cognitive decline with nattokinase will be mediated through hemostatic, fibrinolytic and hemorheological factors as well as attenuation of inflammation, monocyte activation, vascular endothelium injury and activation of vascular endothelium by circulating monocytes. Specific Aims: To conduct a RCT to determine the effect of nattokinase on the progression of subclinical atherosclerosis (primary trial end point) and cognitive decline (secondary trial end point). Healthy non-demented women and men >55 years old without pre-existing symptomatic CVD and diabetes mellitus will be randomized over a 2 year period to oral nattokinase (2,000 fibrinolysis units) daily versus placebo in this double-blind, placebo-controlled trial; randomized treatment will be 3-years. The following 5 major specific aims will be completed: 1. To determine the effect of nattokinase on the progression of subclinical carotid artery atherosclerosis determined as the rate of change of the common carotid artery intima-media thickness (CIMT) and arterial stiffness in computer image processed B-mode ultrasonograms. 2. To determine the effect of nattokinase on cognitive decline determined with a neuropsychological battery designed to evaluate 7 cognitive domains including: attention, concentration, working memory, executive function; visuospatial/visuoconstructive skills; naming/semantic memory; and verbal and nonverbal episodic memory. 2a. To determine the effect of nattokinase on cognitive decline according to apolipoprotein (Apo) E e4 genotype. 3. To determine the association of subclinical atherosclerosis progression with cognitive decline. 4. To determine whether the effects of nattokinase on subclinical atherosclerosis and cognitive decline are mediated through hemostatic (fibrinogen, factor VIII, platelet activity), fibrinolytic (tPA, PAI-1, D-dimer), hemorheological (plasma and blood viscosity, red blood cell aggregation) and inflammatory (MCP-1, IL-8, TNFα, IL-1β, IL-10, monocyte cell surface markers CD11b/CD11c and VLA-4, expression of adhesion molecules VCAM-1 and ICAM-1 in cultured human aortic endothelial cells) factors as well as blood pressure.
Not yet recruiting | Atherosclerosis | Not Multisite
Howard Hodis
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ROVERThe RObotic Vascular & Endovascular Registry
The objectives of the study are to allow the physician to use the commercially available Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets in the peripheral vasculature to: - Determine the number of endovascular procedures consecutively performed with the Magellan Robotic System to navigate to treatment targets in the peripheral vasculature and, - Achieve stable and efficient system preparation and set-up times, navigation and cannulation times of target vessels during endovascular procedures, and placement of therapeutic equipment used to perform endovascular procedures. - Achieve stable and reduced fluoroscopy time during the endovascular procedures. - Determine the number of cases required to reach a "steady state," reduction or predictable time in conducting peripheral interventional procedures using descriptive (means, ranges) statistics to analyze the data. Design This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially enrolling data collection activity (for which Hansen Medical is providing funding). Only patients scheduled to undergo endovascular procedures using the Magellan Robotic System will be approached for enrollment. Methods Registry procedures will be conducted in accordance with the labeled indication for use of the Magellan™ Robotic System. Prior to the physician participating in the registry and prior to subject enrollment, all participating physicians will be required to complete Hansen Medical's Magellan Robotic System training. Participating registry sites must have a commercially available Magellan Robotic System for the treatment of patients. Data Management Participating sites will be assigned a specific site numeric identification code by the registry sponsor. The information collected into the registry will be data related to the procedure in which the Magellan System was used or planned to be used and may include patient follow-up data, minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for the resolution of a procedural or post procedure adverse event. The database will be a repository for the collected registry data and the data will be made available (in extractable format) to the physician participants. Adverse Events The data submitted will be reviewed on a regular basis for safety issues and complaints. Adverse events and/or complaints deemed reportable will be submitted to the appropriate regulatory agency/agencies by Hansen Medical, Inc.
Recruiting | Atherosclerosis | Multisite
Sung Ham
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Multicenter, open-label study to evaluate the safety and efficacy (by blinded reading) of Gadobutrol-enhanced magnetic resonance angiography (MRA) after a single injection of 0.1 mmol/kg of Gadobutrol in subjects with known or suspected renal artery disease
Completed | Atherosclerosis | Multisite
Suzanne Palmer
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Sitagliptin Effects on Arterial Vasoreactivity and Proatherogenic Mediators in Obesity
APPROACH: Overview of Study Design: This is a double-masked, randomized, placebo-controlled pilot study of treatment sitagliptin (100mg/day) to suppress monocyte/macrophage activation in obese non-diabetic participants. 16 abdominally obese18-40 year-old largely minorities will be randomized 3:1 to receive sitagliptin (N=12) or matching placebo (N=4) daily for 28 days. Eligibility Criteria for the Study Cohort: Based on prior studies conducted by the investigators, approximately 60-70% of participants enrolled will be Hispanics and African Americans. Both minorities have increased prevalence of insulin resistance (IR) at young ages. In their prior studies, insulin resistance (HOMA-IR* ≥3.0) had a predictive value of 88% for crown like structure in abdominal fat (a surrogate for fat inflammation); the inclusion criterion for IR will assure that most study subjects will have abdominal fat inflammation. * homeostatic method of analysis-insulin resistance Inclusion Criteria 1. Age 18-40 years of age 2. Stable weight (no change >3% in prior 6 months) 3. Waist circumference ≥102cm for men; ≥88cm for women 4. Fasting plasma glucose 100-125, HgbA1C 5.7-6.4% or HOMA-IR* ≥3.0 Exclusion Criteria: 1. Regular use of a non-steroidal anti-inflammatory drug (NSAID); unwilling to stop NSAID drug 2. On statin or other prescription anti-inflammatory drugs 3. Diabetes or clinically evident cardiovascular disease 4. Smoking daily or consuming >200g alcohol/day Study participants will be adults 18-40 years of age to exclude older persons with irreversible atherosclerosis (e.g. calcified, stenotic plaque) or subclinical arterial thrombus which release inflammatory mediators. Persons with Type 2 diabetes (a myocardial infarction equivalent) and those receiving "statins" (also potent anti-inflammatory drugs) will be excluded, thereby further excluding participants with advanced atherosclerosis. The goal is to identify and study persons with abdominal obesity and inflammation at a younger age as a potential target population for pre-emptive anti-inflammatory therapy to prevent serious CVD events over ensuing years. Outcome Measures: 1. Change in arterial vasoreactivity measured and quantified by ultrasound assessment of brachial artery flow mediated dilation and carotid stiffness (elasticity and distensibility). 2. Change in measures of inflammation in intra-abdominal adipose tissue: 1. M1 pro-inflammatory macrophages and M2 anti-inflammatory macrophages by fluorescent activated cell sorting. 2. Ex vivo secretion of inflammatory mediators from macrophages fractions. 3. Change in systemic pro-inflammatory/pro-atherogenic markers and insulin resistance.
Not yet recruiting | Atherosclerosis | Not Multisite
Fred Sattler
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Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the treatment of Critical Limb Ischemia due to Peripheral Arterial Occlusive Disease
Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The buffy coat is concentrated by removing plasma. The resultant concentrate of cells is injected into ischemic tissues of the lower limb.
Completed | Atherosclerosis | Multisite
Karen Woo
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Carotid revascularization for asymptomatic carotid stenosis by carotid endarterectomy (CEA) or carotid artery stenting (CAS) is common and costly. The rationale for incurring large national costs for revascularization of asymptomatic patients is based on the results of the previous studies all of which were done without comparison to modern intensive medical management. CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. The study is assessing: 1) the treatment differences between MEDICAL management compared with CEA, and 2) the treatment differences between MEDICAL management compared to CAS. Each is a two-arm, randomized trial of approximately 1,240 asymptomatic patients with high-grade stenosis randomized to receive revascularization plus intensive medical management (CAS or CEA) versus intensive medical management alone (MEDICAL). The study population is people aged >35 years old who have high-grade cervical carotid artery stenosis and who are confirmed to be asymptomatic. It is anticipated that approximately 2480 adult men and women will be enrolled. The primary outcome is the composite of stroke plus death (S+D) within 44 days after randomization and ipsilateral ischemic stroke thereafter up to 4 years, and this composite endpoint will be estimated using Kaplan-Meier survival approaches. Statistical testing will employ superiority testing, with the null hypothesis that MEDICAL is equivalent to CAS or CEA versus the alternative that MEDICAL differs from CAS or CEA. Secondary outcomes are: 1) the assessment if MEDICAL differs from CAS, and differs from CEA, to maintain the level of cognitive function at the 4-year assessment, 2) if there are treatment differences in the incidence of major stroke, minor stroke, disabling stroke, non-disabling stroke, and tissue-based stroke at 4-years, and 3) potential effect modification of the CAS or CEA versus MEDICAL differences, based on patient age, sex, severity of carotid stenosis, restenosis, risk factor level, and duration of asymptomatic period.
Recruiting | Atherosclerosis | Multisite
Fred Weaver
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EVOLVE Short DAPT Study: A prospective, multicenter, single-arm, study designed to assess the safety of 3 month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System. The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure. Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg. Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft [CABG], and stent thrombosis) between the index procedure and the 3 month visit. Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use. All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator's discretion and should be followed through the 15-month visit.
| Atherosclerosis | Multisite
Ray Matthews
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International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
BACKGROUND: Evidence supporting a routine invasive practice paradigm for patients with stable ischemic heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions—were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients. COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia level documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cath and revascularization among higher risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cath, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cath, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cath. A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients. DESIGN NARRATIVE: The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0 was approved in January 2014. PARTICIPATING COUNTRIES: North America - Canada - Mexico - USA (~150 sites) South America - Argentina - Brazil - Chile - Peru Asia - China - India - Japan - Singapore - Taiwan - Thailand - Russian Federation Pacifica - Australia - New Zealand Europe - Austria - Belgium - Denmark - France - Germany - Hungary - Italy - Lithuania - Macedonia - Netherlands - Poland - Portugal - Romania - Serbia - Spain - Sweden - UK Middle East - Israel - Saudi Arabia - Turkey
Recruiting | Atherosclerosis | Multisite
Judith Hochman
A Phase 2, Randomized, Open-label (with Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo in Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Completed | Atherosclerosis | Multisite
Fred Weaver
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Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (Shield II)
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 100 sites in the US. Control device will be any Abiomed Impella device approved for use in high-risk PCI. Nonrandomized roll-in phase: Each site must first enroll and treat up to 6 patients (up to 3 PHP and 3 Impella per site) Randomized phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Suspended | Atherosclerosis | Multisite
Ray Matthews
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