15 Clinical Trials for Various Conditions
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
Background: - Heart failure is a common cardiovascular disorder whose incidence increases with age, affecting up to 10% of people older than 65 years of age. As the population ages, the prevalence and cost of heart failure will continue to rise. Researchers are interested in using noninvasive imaging methods to better understand the symptoms and effects of heart failure. Objectives: - To conduct a noninvasive comparative imaging study of individuals with heart failure. Eligibility: - Individuals at least 18 years of age who have been diagnosed with heart failure (with at least mild symptoms and slight limitations on physical activity). Design: * This study will last approximately 2 years and will require four visits to the National Institutes of Health Clinical Center, with one screening visit and three study visits. * Participants will be screened with a full medical history and physical examination, as well as blood and urine samples. * Participants will have the following tests during each study visit: * Physical examination * Blood and urine samples * Cardiac magnetic resonance imaging * Cardiac computerized tomography to study the blood vessels in and leading to the heart * Echocardiogram to evaluate heart function * Electrocardiogram to measure heart electrical activity * The three study visits will take place 1 year apart. Participants will also receive follow-up phone calls 6 months after the first and second visits. * No treatment will be provided as part of this protocol.
This study will evaluate volunteers 18 years of age and older to see if they qualify for one of NHLBI s research studies. Tests include the following: * General medical evaluation, which may include blood tests, chest x-ray, electrocardiogram (ECG) and echocardiogram (heart ultrasound). * Other tests as appropriate, such as magnetic resonance imaging (MRI), cardiac computed tomography (CT scan of the heart), nuclear stress test and echocardiography stress test. * X-ray contrast studies of the heart and blood vessels. (These may be excluded in patients with kidney risk factors.)
There is an important need to maintain clinical skills, provide quality training and expertise, and provide an environment that stimulates ideas for clinical research. This study permits inpatient evaluation and management of patients with heart disease who do not qualify to participate in studies currently being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute.
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of Valvular Heart Disease (VHD).
This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
Background \& Significance. Children with congenital heart disease (CHD) have experienced improved postoperative survival shifting the focus away from minimizing mortality to curtailing morbidities. Critical illness following cardiac surgery induces catabolism which may impact functional status. Catabolism, a state in which protein breakdown exceeds protein synthesis, can lead to lean body mass (LBM) breakdown. LBM loss has been associated with poor clinical outcomes. Muscle ultrasound (mUS) has been utilized to measure LBM changes and the functional status score (FSS) was developed to assess functional status changes in children following hospitalization. The ability to identify LBM loss acutely and its association with FSS changes may lead to earlier interventions to preserve LBM and aid in outcome prediction. Specific Aims \& Hypotheses. Specific Aim 1 is to identify the percent change in LBM by mUS during the first postoperative week in children following complex cardiac surgery. Specific Aim 2 is to evaluate the relationship between percent change in LBM during the first postoperative week and the FSS at discharge and 6 and 12-month follow-up in children with CHD following complex cardiac surgery. The investigators hypothesize children with CHD following complex cardiac surgery will experience a decline in LBM and that there is a direct relationship between the change in LBM and postoperative FSS follow-up. Study Design \& Methods. The investigators are conducting a single-center, prospective, observational cohort study. Consecutive children (\> 3 months and \< 18 years of age) with CHD undergoing biventricular conversion will be enrolled. Patients will undergo a baseline mUS and FSS at the time of the index operation. Interval mUS will be obtained on the third and seventh postoperative day. Discharge mUS and FSS will be obtained and a remote FSS will be requested by the family at 6 and 12-months postoperatively. Demographics, pertinent laboratory, concomitant medications, nutrition and ultrasound variables will be collected. Outcomes. The primary outcomes will be change in LBM during the first postoperative week and change in FSS at 6 and 12-month follow-up in children following complex cardiac surgery. Change in LBM will be defined as a percent change in cross-sectional area of the quadriceps muscle layer thickness (QMLT). Change in FSS will be significant if the score drops 3 points or more from baseline at postoperative follow-up.
When patients receive repeated blood transfusions the level of iron in the patient s blood can rise. When iron is processed in the body a protein known as hemosiderin can begin collecting in the organs. If too much hemosiderin collects in the organs they can begin to malfunction. This condition is called transfusional hemochromatosis. An organ of particular importance in transfusional hemochromatosis is the heart. Patients born with diseases requiring blood transfusions at birth begin to develop heart problems in their teens. These patients typically only live for 17 years. Adults that require transfusions can begin experiencing heart problems after 100-200 units of backed red blood cells. Deferoxamine (Desferal) is a drug that binds to iron and allows it to be excreted from the body. It is the only effective way to remove iron from patients who have been overloaded with iron because of multiple transfusions. Previous studies have lead researchers to believe that deferoxamine, when given as an injection under the skin (subcutaneous), can be delay or prevent heart complications. Researchers plan to continue studying patients receiving deferoxamine as treatment for the prevention of heart complications associated with repeated blood transfusions. In this study researchers will attempt; 1. To determine if deferoxamine, given regularly, can indefinitely prevent the heart, liver, and endocrine complications associated with transfusional hemochromatosis 2. To determine whether heart disease caused by transfusional hemochromatosis can be reversed by intensive treatment with deferoxamine.
Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is conventionally used to infer how likely the stenosis will limit blood flow (called ischemia) under conditions of increased demand (e.g exercise). This is based on animal work and data from humans with simple single vessel disease with no co-existing conditions. These data have been extrapolated to more complex patients/ complex disease but clearly over-simplifies the situation in the majority of patients cardiologists treat. Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure derived measurements, called FFR, from the coronary artery during a cardiac catheterization, more accurately identify stenoses that would cause ischemia compared to visual assessment alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly improved outcomes and reduced costs compared to visual assessment alone (FAME trial). Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent sensitivity and specificity. A FFR of \<=0.80 was used as this identified ischemia causing lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation and treatment deferral has a robust evidence base to support it. Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used by some cardiac surgeons to assess the patency of bypass grafts in real-time in the operating room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson observed that regional myocardial perfusion (RMP) image data was also captured in these video sequences. Study Hypotheses: 1. In patients who are likely CABG candidates, target vessel epicardial coronary arteries (TVECAs) with FFR \> 0.80 will not demonstrate an increase in RMP despite an anatomically patent bypass conduit during SPY® imaging. 2. In TVECAs with an increase in RMP during SPY® imaging, cardiac catheter laboratory measures of coronary physiology from that TVECA, namely one or a combination of FFR, CFR, HSR and HMR, will correlate with the SPY® data on myocardial perfusion, and suggest a potential mechanism for this physiologic response to TVECA grafting.
The investigators will conduct qualitative interviews of hospital personnel regarding HAI prevention practices, and use coded data from these interviews to assist in developing standardized practices.
Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery. We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic \& Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).
Palliative care is believed to improve care of patients with life-limiting illnesses. This study evaluated the impact of a multi-center randomized trial of a palliative care team intervention on the quality and cost of care of hospitalized patients. Study subjects were randomized to intervention or usual care. At study end, patients receiving the palliative care intervention reported greater patient satisfaction with their care. Intervention patients also had significantly fewer ICU admissions and lower total costs for care 6 months past their hospitalization. Intervention patients completed more advance directives and had longer hospice stays.