Electrocardiogram (ECG) refers to the process of recording the heart's electrical activity, widely used in clinical settings to monitor cardiac function and detect abnormalities. Clinical trials involving ECG often evaluate the accuracy and utility o...
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Found 16 Actively Recruiting clinical trials
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This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.
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Researchers are exploring how deep brain nuclei activity and the cerebral cortex function during recovery from general anesthesia in patients undergoing deep brain stimulation (DBS) surgery. This study aims to understand the changes and connections between deep brain nuclei firing and cortical activity during the return of consciousness. The research focuses on the brain's neural networks involved in recovery, which is not just a passive drug clearing process but an active brain function. During the study, patients having DBS surgery will have their local field potentials (LFP) from deep brain nuclei and scalp electroencephalograms (EEG) from the frontal cortex recorded simultaneously. No additional interventions are given beyond the planned DBS surgery. These recordings occur during the recovery period after general anesthesia to analyze how signals from deep brain areas relate to cortical EEG activity. Participants will be monitored for changes in brain signals over about 2 hours during recovery from anesthesia. Researchers will evaluate the number of patients showing changes in LFP and EEG patterns. The study includes assessments of brain activity to better understand consciousness recovery mechanisms. Patients are expected to cooperate during surgery and recording, with the total observation focused on the immediate post-anesthesia recovery phase.
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Researchers are studying how friendship experiences affect adolescents who have been maltreated compared to those who have not. The study aims to understand differences in friendships and how these relationships influence stress regulation, mental health outcomes, and risk of revictimization in adolescents aged 13 to 17. It focuses on the role friends play in these processes and how maltreatment impacts adolescent development. Participants will be involved in a laboratory visit where they complete questionnaires and undergo a stress test called the Trier Social Stress Test (TSST). They will be randomly assigned to either discuss their stress experience with a close friend or sit quietly alone for five minutes afterward. The adolescents' heart activity related to stress regulation will be recorded using an electrocardiogram during the test and the post-test period. The interaction with the friend will be audio and video recorded for analysis of supportive or unsupportive behaviors. Participants and their caregivers will complete questionnaires at the start and again six months later, either online or by mail. The study measures include heart rate variability at baseline, mental health reports, posttraumatic stress symptoms, and experiences of revictimization after six months. Researchers will monitor the adolescents' ability to manage stress and how friendships may influence their mental health and risk over time. The total involvement includes an initial lab visit and a follow-up assessment half a year later.
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Researchers are investigating new diagnostic and prognostic markers for cardiomyopathy (CMP) to better predict how the disease progresses, especially toward heart failure or the need for heart transplantation. The study focuses on microRNAs and spatial transcriptomics, promising techniques that may reveal important disease mechanisms. Patients with various types of CMP, including hypertrophic, dilated, arrhythmogenic, and forms related to amyloidosis and Fabry disease, are being evaluated to improve diagnosis and management. This observational study has both retrospective and prospective parts. Retrospective data from patients treated since 1990 will be collected from medical records, while prospective patients are enrolled from outpatient or inpatient settings at several medical centers. Patients undergo standard clinical tests such as ECG, echocardiograms, cardiac magnetic resonance (CMR), biopsies, and genetic testing. Additional molecular analyses on blood plasma and cardiac tissue will be done for some prospective patients. Tissue samples collected during routine biopsies or surgeries will be processed for advanced RNA analyses. Participants will provide informed consent and be evaluated according to clinical needs without a set minimum follow-up time. Data collected include demographics, medical and family history, symptoms, treatments, and genetic information. Researchers will use this information to identify new biomarkers related to CMP diagnosis and prognosis. The main outcome focuses on risk stratification over a follow-up of two years after a 30-month enrollment period, with data analysis lasting six months. Molecular studies of gene expression and microRNAs will also be analyzed during this time.
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This research focuses on patients who have left bundle branch block (LBBB) as seen on their ECG. The study aims to explore the clinical, ECG, and imaging features in a large group of these patients. It seeks to find factors that predict when LBBB causes left ventricular systolic dysfunction and to identify outcomes for this population, with the goal of providing data that may influence treatment approaches. Participants will undergo clinical and instrumental follow-up using diagnostic tests such as ECG, echocardiogram, and magnetic resonance imaging. These assessments will help monitor heart function and detect changes over time. The study is observational, meaning it tracks patients without assigning specific treatments. Throughout the study, participants will be regularly evaluated using these tests to monitor left ventricular function and any cardiovascular events like heart failure. The main outcome measured is left ventricular dysfunction over a follow-up period of 20 years. Secondary outcomes include adverse cardiovascular events. This long-term monitoring helps researchers understand the progression and impact of LBBB on heart health.
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Atrial fibrillation (AF) is a common irregular and often fast heart rhythm affecting adults worldwide, with increasing incidence and prevalence. It is linked to higher health risks and other conditions like hypertension and diabetes, impacting patients and healthcare systems. The European Society of Cardiology recommends an integrated care model that includes catheter ablation to manage symptoms and physical activity to improve health, but the effects of exercise after ablation are not well established. This randomized controlled trial aims to study how a 12-week physical exercise program influences patients who underwent catheter ablation for AF at least one year ago. Participants will be randomly assigned to either an exercise group, which will do concurrent strength and aerobic training three times a week with progressively increasing duration and intensity, or a control group receiving usual care without intervention. The exercise sessions include warm-up, resistance training with free weights, aerobic training on a cycle ergometer, and cool-down stretches. Participants will be evaluated three times: before the intervention, after three months of training, and six months after recruitment to assess lasting effects. Assessments include body composition, ECG, echocardiogram, physical activity monitoring, sleep analysis, muscle strength, cardiorespiratory capacity, quality of life, and AF burden. Attendance at exercise sessions will be recorded to monitor adherence, and safety insurance covers potential risks during training and evaluations.
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This research focuses on patients undergoing laparoscopic colorectal surgery for various conditions. It aims to evaluate heart rate variability (HRV) parameters, such as RMSSD, before and after surgery to understand how surgical effects and possible complications impact these measurements and relate to specific adverse outcomes. Participants receive standard colorectal surgery followed by monitoring using the PulseOn device to measure HRV after the operation. The study specifically examines changes in HRV within three days post-surgery to assess recovery and complications. During the study, participants' HRV is tracked before and after surgery, with data collected via the PulseOn device. Researchers monitor HRV changes and complications to evaluate recovery quality. The total participation involves preoperative and postoperative assessments focused on physiological monitoring within the first few days after surgery.
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Researchers are investigating the use of a Deep Learning (DL) model to analyze electrocardiogram (ECG) traces from athletes to provide a probability-based assessment of cardiovascular disease risk. This observational study aims to develop and validate this model to help determine athletes' eligibility for competitive sports. The study follows current guidelines and cardiological standards for evaluating athletes' heart health. The study involves two groups of athletes. The first group of 455 athletes has already undergone standard clinical evaluations for sports participation clearance; their ECGs and clinical results will be used to train the DL model. The second group of 76 athletes will be evaluated using standard fitness tests and the DL model to validate its accuracy. Participants in both groups are classified as "fit" or "unfit" for competitive sports based on medical assessments. Participants will undergo ECG tests and clinical evaluations according to established cardiological guidelines. Researchers will collect and analyze ECG data to train and test the DL model, measuring its accuracy, sensitivity, and specificity in classifying athletes' fitness for competition. The study duration for each participant can last up to 12 months from the first medical evaluation to the final decision on sports eligibility.
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Diabetes, especially type 2 diabetes (T2DM) with insulin resistance, is linked to an increased risk of sudden cardiac death. This risk is partly related to changes in the heart's electrical activity, measured by QTc interval prolongation on ECGs. Researchers are studying how the antibiotic moxifloxacin might worsen QTc prolongation in people with T2DM, particularly when blood sugar levels are high or insulin is deficient. The study also aims to explore differences between males and females and analyze blood markers to understand the molecular reasons behind these effects. Participants in this study will receive controlled doses of glucose and moxifloxacin or placebos in a randomized, single-blind setting. On Day 1, participants get glucose with a placebo for moxifloxacin, while on Day 3 they receive intravenous glucose combined with moxifloxacin infused over 45 minutes. Blood glucose levels will be carefully raised and maintained at high levels for a set time, monitored continuously with glucose sensors and blood samples. The study includes both inpatient stays for treatment and outpatient follow-up visits. During the study, participants will undergo regular ECGs to measure heart electrical activity, blood tests to track glucose and moxifloxacin levels, and monitoring for any side effects. Outcomes measured include changes in ECG intervals and heart rhythms, pharmacokinetic profiles of glucose and moxifloxacin, and differences between sexes. The trial lasts several days with follow-up visits up to about 75 days after initial treatment to ensure participant safety and collect final data.
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Researchers are investigating the effects of methadone compared to hydromorphone on the QT interval of the electrocardiogram (EKG) in patients undergoing general anesthesia for surgery. The study focuses on understanding whether a single dose of intravenous methadone, given at anesthesia induction, causes significant QT prolongation, which can lead to a dangerous heart rhythm called torsade des pointes. This clinical trial is randomized and quadruple-blinded, aiming to clarify the cardiac safety of methadone use during surgery, as previous studies in chronic methadone users showed increased risk but the impact of a single dose during surgery remains unclear. Participants are randomly assigned to receive either methadone at induction of anesthesia followed by saline at the end, or saline at induction followed by hydromorphone at the end. Both drugs are opioids used for managing moderate-to-severe postoperative pain. The study measures the QT interval using a 12-lead EKG 30 minutes after admission to the postanesthesia care unit (PACU) and again on the morning after surgery (postoperative day one). Secondary outcomes include pain levels and opioid-related complications. During the study, patients will have EKGs performed at specified time points to monitor QT prolongation. Pain levels will be assessed using a 0-10 scale both in the PACU and the following morning. Researchers will also observe for any sedation or respiratory complications related to opioid use. The total participation includes the surgery day and follow-up assessments on the first postoperative day. This trial aims to provide detailed safety and pain management data for methadone use in the perioperative setting.
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