114 Clinical Trials for Various Conditions
The goal of this observational study is to quantify ergonomic risk associated with traditional protective equipment in operators working in the cardiac catheterization laboratory as compared with a mobile protection system. The main questions it aims to answer is: What is the mean time spent by operators in positions of high ergonomic postural risk during cases? Participants will wear IMU, EMG, and radiation sensors, as well as complete baseline and discomfort surveys for several catheterization procedures.
Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.
This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.
Moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. Whether being in a fasting state (nothing per os, NPO) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. Whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time. We aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept NPO prior to cardiac catheterization.
This is a prospective, single center study which applies a standardized, comprehensive catheterization assessment to patients with a known or suspected diagnosis of pulmonary vein stenosis (PVS) who are undergoing a cardiac catheterization at Boston Children's Hospital. As part of the assessment, each pulmonary vein will undergo angiography (pictures using moving x-rays and contrast dye), intravascular ultrasound (IVUS; pictures of the vein wall using a catheter inside the vein), pressure assessment and compliance testing. The status of each pulmonary vein will then be assessed 12 months after the catheterization (i.e. no disease, severe disease, etc.). Using statistics, the investigators will determine which patient and vein characteristics (obtained at the of catheterization) can predict whether or not a pulmonary vein will have disease. The investigators hypothesize that this comprehensive, standardized, invasive assessment of pediatric intraluminal PVS can predict vein outcome.
The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation. Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making.
This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.
The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.
It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. The investigators hypothesize that determining which individuals with coronary artery disease should receive nicotine replacement therapy based on their genotype may improve the number of individuals who are able to quit smoking.This study randomizes treatment to that determined by the patient's genotype compared to standard, non-genotype-guided, treatment.
Contrast agent is typically used during routine cardiac intervention in order to enhance the imaging necessary to perform the procedure. Using this contrast agent could lead to kidney injury, called contrast induced nephropathy (CIN). Currently, the methods used to reduce the risk of CIN include reducing the amount of contrast agent used and using a hydration strategy during procedure. A computer-based risk tool has been developed which reports a risk score for the likelihood a person undergoing cardiac intervention gets CIN and a proposed corresponding hydration strategy to reduce the risk of CIN. The purpose of this study is to determine whether the rate of CIN decreases when the treating physician has access to this risk tool during the procedure.
Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes. Objectives: To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy. Eligibility: Adults 18 and older whose doctors have recommended right heart catheterization. Design: Researchers will screen participants by reviewing their lab results and questionnaire answers. Participants may give 4 blood samples. Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one. Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body. Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time. During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.
Hemodynamic measurements obtained during pulmonary artery catheterization are essential for the diagnosis and classification of pulmonary hypertension. Traditionally, right heart catheterization (RHC) is done in the supine position. Cardiac output is known to change significantly based on position, due to the effects of gravity on venous return. There has not been a systematic investigation into these postural effects on pulmonary arterial pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to study the differences in measurements obtained during RHC when the patient is supine, seated, and standing.
The investigators will conduct a randomized controlled trial that aims to compare the incidence of contrast-induced nephropathy between transradial- and transfemoral-access cardiac catheterization.
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.
The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.
Radiation exposure to operator is an occupational hazard of invasive cardiologists. During radial access for diagnostic catheterization, a new radio-dense arm board is advertised to reduce operator radiation exposure. The investigators randomize patients to a new radio-dense armboard versus a standard radio-transparent armboard during diagnostic catheterization and measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in place. The investigators hypothesize that operator radiation dose will be decreased by use of the radio-dense armboard.
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities. The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.
Cortisol is essential for survival. The importance of cortisol response is most apparent in patients with partial or complete deficiency of glucocorticoids during stressful events such as illness or surgery.
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization). The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.
The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.
Background: - Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization. Objectives: - To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters. Eligibility: - Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure. Design: * The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization. * Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.
Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating stopping rules to optimize safety of the drug in this population. The second part of this study will evaluate if the lowest safest dose, as determined in part 1, is adequate to provide effective sedation during a cardiac catheterization procedure.
Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO) randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to early (before dismissal) graft angiography vs. no early graft angiography. Coronary angiography will be performed at 12 months, to determine whether compared to no early graft angiography, early graft angiography will result in: 1. lower per patient angiographic bypass graft failure (in at least one graft) rates (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy endpoint) 2. lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints) 3. lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (secondary endpoint) Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at least one bypass graft at baseline (in the early graft angiography group only) and at 12-month angiographic follow-up to evaluate the structural bypass graft changes occurring after coronary artery bypass graft surgery (secondary endpoint).
Cardiac catheterization has traditionally been performed via access to the arterial circulation from the femoral artery located in the groin. As an alternative to this approach, the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple studies have demonstrated that cardiac catheterization via the radial approach has a very low complication rate, in the short term. This study is intended to determine if there are any differences in the long term complication rate between radial artery cardiac catheterization as compared with femoral artery cardiac catheterization.
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.