Treatment Trials

249 Clinical Trials for Various Conditions

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Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department
Description

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.

Conditions

ACS (Acute Coronary Syndrome)

Virtual Reality for Non-cardiac Chest Pain
Description

The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).

Conditions

Gastrointestinal Diseases, Chest Pain

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
Description

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.

Conditions

Chest Pain

A Study to Assess the Accuracy of Magnetocardiography (MCG) to Diagnose True Ischemia in Patients With Chest Pain in the ED
Description

The purpose of the research is to see if patients that come to the Emergency Department with chest pain can be more accurately and more quickly diagnosed by magnetocardiography (MCG) to see if their chest pain is caused by coronary ischemia (reduced blood flow to the heart) in patients with normal or have non-specific changes on the ECG vs other causes by other reasons.

Conditions

Chest Pain, Emergency Medicine

Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Description

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.

Conditions

Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

A Care Management Intervention for Non-cardiac Chest Pain
Description

The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.

Conditions

Chest Pain

Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Description

The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption.

Conditions

Generalized Anxiety Disorder, Chest Pain, Panic

Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain
Description

This will be a prospective cross-sectional study evaluating a convenience sample of patients in the ED with low-risk chest pain defined by a HEART score of 3 or less.

Conditions

Chest Pain, Cardiac Event

A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Description

This study aims to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in emergency department (ED) patients admitted with chest pain and low-risk features.

Conditions

Telemetry Usage, Chest Pain, Unstable Angina, Resource Utilization

The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain
Description

This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.

Conditions

Cardiology, Radiology, Stenoses

"SVEAT" Chest Pain Scoring System
Description

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.

Conditions

Chest Pain

Prehospital Translation of Chest Pain Tools
Description

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.

Conditions

Acute Coronary Syndrome, Pulmonary Embolism

Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Description

This Emergency Department based study investigates the feasibility and effectiveness of a mindfulness based stress reduction (MBSR) training program referral for patients with chest pain at low risk for acute coronary syndrome but associated with anxiety. Outcomes assessed for eligible patients randomized to MBSR vs. usual care include mental health (longitudinal Generalized Anxiety Disorder - 7 (GAD-7) scores), quality of life (PROMIS Global Short Form), and ED resource utilization (return Emergency Department (ED) visits).

Conditions

Chest Pain, Anxiety, Mindfulness

Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
Description

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.

Conditions

Acute Coronary Syndrome, Myocardial Infarction

Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery
Description

The post-thoracotomy pain (PTP) has been defined as persistent or recurrent pain that lasts for at least 2 month after thoracotomy and is associated with surgical incision or its intercostal nerve cutaneous distribution. The latter has a prevalence of about 15% to 20%. In about 80% of the patients such pain is moderate to severe in intensity and is associated with depression and insomnia. According to its characteristics and possible etiology, PTP is part of the neuropathic pain syndromes. Patients describe their chest wall pain as shooting, burning and numbness which are descriptors often seen in other neuropathic pain syndromes. PTP occurs most likely after partial or complete intercostal nerve damage secondary mechanical trauma (nerve traction or compression) during surgery. The concern is that when robotic surgery for minimally invasive approach to the heart valves or vessels such compression and consequent damage may happen to intercostal nerves. Therapeutic use for a lidocaine patch include post-herpetic neuralgia postthoracotomy pain, stump neuroma pain, intercostal neuralgia, diabetic polyneuropathy, meralgia paresthetica, complex regional pain syndrome, radiculopathy, postmastectomy pain and some other focal peripheral neuropathic pain syndromes. It is an effective and safe topical treatment. Its efficacy demonstrated previously in treatment of intercostal neuralgia and some patients with post-thoracotomy syndrome can be used in treatment of perioperative chest pain related to robotic cardiac surgery. Hypothesis is that the use of topical lidocaine will decrease pain in acute phase after the surgery and decrease intensity of post-thoracotomy pain 6 months after such procedure. The effect of topical 5% lidocaine will be clinically evaluated through prospective, randomized, placebo, double-blind study. Each patient will be assessed at admission and then, one week after Valve Replacement (Recommended surgical procedures do not included harvesting of leg vessels as this could be a potential confounder). Then, one month, three and six month follow-up for all patients by mailing questionnaires and phone calls. Upon admission, as well as 1 week, 1month, 3months and 6 months following surgical procedure, the following tests will be performed: * Pain Disability Index (PDI) * DASS * VAS Pain Score * Opioid use (in MSO4 mg equivalents) * Global Perceived Effect (GPE) or patient satisfaction

Conditions

Perioperative Chest Pain

High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Description

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.

Conditions

Acute Coronary Syndrome, Chest Pain

Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
Description

This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.

Conditions

Chest Pain

Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
Description

In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were not adversely affected by this regiment. In fact, some cholesterol measures trended in a favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the dose and extending the duration will continue to show an improvement in symptoms as well as no adverse metabolic outcomes.

Conditions

Esophageal Diseases

Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion
Description

This is a prospective open label two arms clinical trial. ARM-A patients will receive the standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial perfusion with new Revolution CT scanner (General Electric Healthcare) while the Group-2 will receive SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital (WKBH). The primary hypothesis is that the combined evaluation of CT angiography with CT myocardial perfusion is more efficient in detecting or excluding acute coronary syndrome resulting in early discharge and decrease length of stay of patients from the Emergency Department (ED) compared to a strategy with SPECT alone. The secondary hypothesis is that a strategy with CTA/CTP can reduce direct patient care costs and potentially improve patient outcomes in the same patient population when compared to a strategy with SPECT imaging alone. The main purpose of this study is to have a definite ED chest pain admission triage, which will help to reduce the length of stay and direct patient cost. This approach will reduce the economic burden in intermediate risk group patients as well. We had a Baptist statistician run the numbers. This study will provide important preliminary data to guide clinical implementation of CTP/CTA in clinical practice. We divided arm B into two groups as the CT protocol might be different at each hospital, so we want to reduce bias as a result of variation in clinical patterns in the different hospitals. Also, we kept 50 patients in arm A (Baptist hospital) to have a control group at the hospital level.

Conditions

Chest Pain

Chest Pain Perception and Capsaicin Sensitivity in Patients With Acute Cardiac Ischemia
Description

The purpose of this study is to determine whether there is a positive correlation between the ability to sense chest pain in the context of myocardial ischemia and the ability to sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active ingredient on hot chili peppers).

Conditions

Chest Pain

Chest Pain Perception and Capsaicin Sensitivity
Description

The purpose of this study is to determine whether there is a positive correlation between the ability to sense chest pain in the context of myocardial ischemia and the ability to sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active ingredient on hot chili peppers). Patients undergoing clinical elective balloon angioplasty of a coronary stenosis will be asked to quantify the subjective intensity of any chest pain they feel during a standardized episode of myocardial ischemia produced by a one-minute coronary balloon occlusion, using a previously-validated numeric rating scale. The same patients will subsequently be asked to grade the subjective intensity of cutaneous discomfort resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an over-the-counter product approved for topical application to treat muscle and joint aches) to the forearm. The goal will be to determine whether an association can be demonstrated between the subjective perception of ischemic chest pain during coronary balloon occlusion and cutaneous capsaicin sensitivity. Such an association could have considerable clinical value, as it might allow physicians to prospectively assess an individual's ability to perceive myocardial ischemia/infarction by assessing his/her subjective response to the topical application of capsaicin.

Conditions

Chest Pain

Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
Description

To assess the ability of a novel 3rd generation dual-source CT system to demonstrate myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute chest pain.

Conditions

Chest Pain

Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
Description

To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.

Conditions

Angina

Myocardial Ischemia Detection for Early Identification of Patients With Ischemic Chest Pain
Description

The purpose of this study is to evaluate whether new novel markers from the clinical electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can detect coronary artery disease in patients with chest pain. The researchers are especially interested in studying how changes in these unique waves evolve over time with rest and activity. It is hoped that the findings will be helpful in differentiating patients with cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early identification can accelerate treatment and save lives. Eligible participants are those age 18 and older who have been referred for a nuclear stress test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary artery disease as part of their clinical care.

Conditions

Cardiac Ischemia, Chest Pain, Shortness of Breath

Stress CT Perfusion in Patients With Chest Pain
Description

Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during vasodilator stress can accurately identify patients presenting at the emergency department with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid in the identification of individuals most likely to benefit from revascularization, and thus improve the ability to predict patient outcomes. Our goals are: 1. to test the above hypothesis by comparing stress MDCT perfusion data with invasive fractional flow reserve (FFR) data in patients with significant stenosis who undergo ICA; 2. to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting patient outcomes.

Conditions

Coronary Artery Disease

Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
Description

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.

Conditions

Chest Pain, Acute Coronary Syndrome

Are Serial Electrocardiograms Additive to SeriAl Second-generations Troponins in Predicting Acute CoronAry Syndromes in PatienTs With Undifferentiated cHest Pain
Description

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.

Conditions

Acute Coronary Syndrome, Chest Pain

Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin
Description

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.

Conditions

Acute Coronary Syndrome, Chest Pain

Ranolazine for the Treatment of Chest Pain in HCM Patients
Description

The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).

Conditions

Hypertrophic Cardiomyopathy

Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Description

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.

Conditions

Acute Coronary Syndrome, Chest Pain