54 Clinical Trials for Various Conditions
The purpose of this research study is to evaluate a better way of diagnosing heart artery disease, heart attack and damage to the heart muscle early on. Currently, it often takes several hours after admission before lab tests will show that there has been any damage to the heart muscle. Although the standard electrocardiogram is quick and non-painful it may miss many cases of significant coronary heart disease. The investigators are proposing that a new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to predict the presence of significant coronary heart disease early on before other studies become positive. The investigators hope by this that the investigators can develop an algorithm for better triage and management of patients with chest pain. This research study is designed to test the effectiveness of the investigational use of the Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact measurement and display of the magnetic fields of the heart generated by the electrical currents, it is not yet approved for the specific diagnosis of heart artery disease (ischemia).
The purpose of this research is to determine the efficiency of a single dual source computed tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS), pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols. Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital stay, the diagnostic imaging test utilization, and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort.
The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical decision aid for the care of patients with chest pain, in a "real-world" clinical setting. This will be accomplished through the building of a transformative collaboration between research, education, and health systems operations to more effectively and efficiently provide patient care.
The purpose of this clinical trial is to study the ability of a radioactive drug called "Technetium Glucarate" to detect whether the cause of chest pain in patients entering the emergency department with no obvious signs of heart attack is due to a condition called Acute Coronary Syndrome (ACS). The drug will be injected intravenously. After one or two hours the patient will undergo an imaging procedure to detect if the drug has accumulated in the heart. Uptake of the radioactive drug in the heart is indicative of reduced blood flow to the heart.
Our research will examine whether the presence or absence of serial electrocardiogram (ECG) changes aids in reclassifying participants' risk for major adverse cardiac events (MACE) over and above serial blood testing.
The goal of this proposal is to improve the quality and value of care for patients with acute chest pain by investigating the potential impact of point-of-care (POC) high sensitivity cardiac troponin (hs-cTn) testing in the Emergency Department (ED) and exploring how best to integrate POC hs-cTnl into ED risk stratification workflows. The study hypothesizes that the Abbott i-STAT POC hs-cTnI assay will decrease time-to-result (TTR) and ED length of stay (LOS), while increasing ED revenue for patients with acute chest pain compared to a strategy of central laboratory hs-cTnI testing.
The goal of this study is to determine if rapid outpatient evaluation vs hospitalization management is the best strategy (based on patient-centered measures and safe, equitable, and efficient resource use) for evaluating patients with acute chest pain who are at moderate risk for acute coronary syndrome (ACS). Patients will be randomized in the Emergency Department to either an outpatient evaluation (CARE-CP) or hospitalization evaluation for their symptoms.
The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).
This is a prospective, observational study to assess the efficacy of the newly developed SVEAT scoring system in identifying low-risk patients who may be eligible for early discharge. Various elements of clinical information including Symptoms, Vascular history, EKG, Age and Troponin values will be checked and entered on the scoring form to calculate the SVEAT risk score. Additionally, HEART score and TIMI risk score will be calculated for the same subjects. The primary aim is to assess the positive and negative predictive values for the SVEAT index for cardiovascular events and compare it to the HEART and TIMI Scores.
Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.
Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia. This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI). Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.
This is a prospective observational cohort study of ED patients with acute chest pain or other symptoms suggestive of ACS. Blood samples will be collected from study participants for High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for research purposes only. Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes.
This prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during coronary angiography in the cardiac catheterization suite. In addition, we plan to determine if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from two or all three scores yields a new tool that exceeds the predictive performance of all three current models for determining the absence or presence of OCAD.
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following: 1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial. Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events. 2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment. Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
The broad, long-term objective is to improve outcomes by optimizing healthcare delivery processes for patients with detectable to elevated serum troponin. This clinical trial involving emergency department (ED) patients with intermediate to high-risk chest pain and detectable to minimally elevated serum troponin within 6 hours of evaluation.
Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.
The purpose of this study is to measure T-Wave Alternans (TWA) in patients with acute coronary syndrome. Researchers are blinded to clinical TWA measurements. The investigators will then try to determine if T-Wave alternans correlates with clinical outcome of patients with Acute Coronary Syndrome. During routine care of the patient, the T Wave Alternans is measured.
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.
We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.
Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.
This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares types of cardiac tests performed while receiving treatment in an observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.
The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.
The purpose of this study is to evaluate whether 64-slice Computed Tomographic coronary angiography is useful for rapid diagnosis or exclusion of significant coronary artery disease in patients who present to the Emergency Department with chest pain.
The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used. The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.
The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.