38 Clinical Trials for Various Conditions
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to \~30% of men and \~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.
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.
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients. Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for a minimum of one year for both primary and secondary outcomes.
The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk. This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome. Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.
The goal of this clinical trial is to that Sodium-glucose cotransporter 2 inhibitors treatment will improve Coronary Microvascular Disease with anginal symptoms associated with non-obstructive coronary disease in women. The main questions it aims to answer are: Aim 1: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves coronary microvascular disease in women with no evidence of epicardial obstructive coronary artery disease. Aim 2: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves angina symptoms and other quality of life measurements associated with the improvement of CFR. AIM 3: Identify the effect of Sodium-glucose cotransporter 2 inhibition on inflammation pathways and markers of systemic Research will compare Dapagliflozin to placebo Participants will: * Take study drug or placebo for 12 weeks * Stress Cardiac magnetic resonance imaging * 12 lead electrocardiograms * Complete questionnaires
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.
Background: - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans. Objectives: - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans. Eligibility: - Healthy volunteers between 18 and 45 years of age. Design: * Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions. * Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study. * Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan. * An additional blood sample will be collected within 1 week of the second MRI scan.
Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well known that the reduction of cholesterol levels by statin therapy is associated with significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin respectively reduced progression of coronary atherosclerosis, even causing plaque regression of some lesions. CAD clinical events are related to plaque instability due to lipid content and activity within the atherosclerotic plaque. The investigators recently completed the YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was associated with a reduction in the amount of lipid in obstructive coronary plaques, as measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and build upon these results, and to provide mechanistic insights into the potential benefits of intensive statin therapy on atherosclerotic plaques.
This study offers catheter-based treatment of heart or artery disease. This protocol permits treatment of patients with cardiovascular diseases who may not be eligible to participate in current research protocols. The treatment offered in this protocol is not experimental, but rather standard treatment provided in most large referral hospitals in the United States. Patients 18 years of age and older who are candidates for catheter-based treatment of obstructive artery disease, including blocked blood flow in a coronary artery (artery to the heart) or in an artery of the arm, leg, brain or kidney may be eligible for this study. Candidates are screened with a general medical evaluation that may include blood tests, magnetic resonance imaging, and monitoring of heart rate and rhythm. Participants undergo angioplasty or stenting for blockage in an artery to the heart or an artery of the arm, leg, brain or kidney. The procedure uses a balloon-tipped catheter to open the blocked artery and likely requires permanent implantation of a metal tube (stent) to improve blood flow through the vessel. During the procedure, the patient is given a sedative and pain medication, if needed.
The purpose of this study is to see if inorganic nitrate in the form of beetroot juice helps blood flow and physical fitness in women with ANOCA and CMD. The main questions it aims to answer are: AIM 1: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase cardiac perfusion and improve quality of life compared to placebo. AIM 2: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase physical fitness and reduce angina and dyspnea symptoms compared to placebo. Exploratory AIM 3: Test the hypothesis that fourteen days of nitrate rich beetroot juice will improve vascular health and function. Participants will: * Take study beverage for 4 weeks total. * Stress Cardiac magnetic resonance imaging and 12 lead electrocardiograms * Complete questionnaires * Cycling exercise test * Non invasive vascular testing * Blood draws
This single-arm, multi-center, prospective study will assess the coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and determinants thereof (transit time, Pa, Pd) in patients before and after intracoronary nitroglycerine.
Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million people in the United States alone, and 112 million people globally. Despite this, 4 in 10 patients undergoing elective coronary angiography for angina and ischemia do not have evidence of obstructive coronary artery disease (CAD). This condition of ischemia with no obstructive CAD (INOCA) is associated with high clinical and economic morbidity, as these patients have a higher rate of repeat procedures and hospitalizations, worse quality of life, future adverse cardiovascular events and frequent time missed from work. The overall objective of this study is to develop and validate a non-invasive algorithm for diagnosis and management of patients with INOCA and suspected microvascular dysfunction centered around cardiac PET MPI. A secondary goal of the study is to assess for improvement in patient symptoms, function and quality of life from PET-guided management of CMD in patients with INOCA. This study will take place at Mount Sinai Morningside in the PET and CTunit on the 3rd floor. The sub-study will occur at Mount Sinai Morningside Cath Lab on the 3rd floor. The study will enroll an estimated total of 70 subjects, 12 of which will also participate in the sub-study. The study is estimated to last 2 years.
According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). INOCA is defined as patients presenting with signs or symptoms of ischemia but no obstructive artery disease. Women are more likely than men to die from cardiovascular disease and more likely to present with no obstructive coronary artery disease. Patients who present with signs and symptoms suggestive of INOCA/MINOCA are also presenting with Coronary Microvascular Dysfunction (CMD). Coronary Microvascular Dysfunction is a dysfunction in the epicardial and/or microvascular endothelial and/or nonendothelial that limits myocardial perfusion. Today, there is no routinely offered/available noninvasive test that is used for the diagnosis of CMD, significantly hindering the ability to identify the disease in the standard of care. Magenetocardiography (MCG) has the opportunity to use its noninvasive imaging techniques to provide early management of CMD. Magnetocardiography (MCG) is a noninvasive imaging modality that has been extensively studied, over the past several decades, as a diagnostic imaging solution for various forms of cardiovascular disease. MCG measures the magnetic field that arises from the electrical activity of the heart's pacemaker activity, the very same activity which yield surface electric field potentials as measured by the electrocardiogram. Since MCG is a functional assessor of repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic to identify CMD in patients who would otherwise have normal coronary CT angiograms and/or stress tests. The proposed study intends to study the diagnostic accuracy of MCG in this population, with the goal of providing early and noninvasive insights for management of CMD. There will be a 12-month duration of the study where the investigators propose to collect MCG scans from approximately 150 patients who present to the Genetesis facility for a 15-minute CardioFlux scan appointment.
This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs. The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of CLBS16 or placebo.
The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE) 20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina. Secondary outcomes include quality of life, time to "return to duty"/work, health resource consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be adjudicated by an experienced Clinical Events Committee (CEC). Follow-up will be 3-years using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National Patient-Centered Clinical Research Network (PCORnet) clinical data research network (CDRN)(OneFlorida Consortium). This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.
Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels. Phase analysis is a computer method that is applied after the PET test is done. It is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. That is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart. This study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion PET studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. This information will be used as a proxy for poor blood supply. The gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
In this study, quantitative characterization of plaque using coronary computed tomographic angiography (CTA) will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms. The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque.
The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims: Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure. Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (\> 24 hours), pneumonia, and/or tracheostomy. Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.
The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
The overall goal of the IQ-MAPLE project is to improve the quality of care provided to patients with several heart, lung and blood conditions by facilitating more accurate and complete problem list documentation. In the first aim, the investigators will design and validate a series of problem inference algorithms, using rule-based techniques on structured data in the electronic health record (EHR) and natural language processing on unstructured data. Both of these techniques will yield candidate problems that the patient is likely to have, and the results will be integrated. In Aim 2, the investigators will design clinical decision support interventions in the EHRs of the four study sites to alert physicians when a candidate problem is detected that is missing from the patient's problem list - the clinician will then be able to accept the alert and add the problem, override the alert, or ignore it entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate the effect of the problem list alert on three endpoints: alert acceptance, problem list addition rate and clinical quality.
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs. In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.