Pericarditis involves inflammation of the pericardium, the protective lining around the heart. Clinical trials in this area explore treatment evaluations to manage inflammation and symptoms, aiming to improve quality of life and reduce recurrence. Re...
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Found 19 Actively Recruiting clinical trials
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Researchers are evaluating a new 10-minute cardiovascular magnetic resonance CMR imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.
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Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index MDPI to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass CPB. This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.
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Researchers are studying VTX2735 to understand its safety and effectiveness in people diagnosed with Recurrent Pericarditis. This Phase 2a open-label pilot study aims to evaluate how well participants tolerate the drug and how it affects pain and inflammation related to their condition. Participants will be adults aged 18 to 75 years who have experienced an episode of pericarditis and currently have symptoms or a risk of recurrence within the next four weeks. The study includes three groups Cohorts A, B, and C with different dosing schedules of VTX2735. Each cohort begins with a 30-day screening period to assess eligibility. Cohort A participants receive Dose A daily for 6 weeks, with possible extensions including the same dose or Dose B for up to 7 weeks and 11 weeks respectively, followed by a 14-day follow-up. Cohorts B and C also receive daily doses of VTX2735 various doses B, C, D, or E during a 6-week treatment period, with possible 18-week extension periods and a 14-day follow-up. Participants will have their symptoms, such as pericardial pain and inflammation, monitored regularly during treatment. Safety and tolerability of VTX2735 are tracked from the first day of treatment through study completion, up to 26 weeks. The study involves assessments like pain scoring and blood tests for inflammation markers. Overall, participants can expect regular visits for treatment, monitoring, and follow-up over several months as researchers gather information on the drugs effects and safety.
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This research aims to explore the relationship between high levels of Galectin-3 and the risk of developing post-operative atrial fibrillation after isolated coronary artery bypass grafting CABG. It also evaluates whether elevated Galectin-3 levels are linked to other post-operative complications and major adverse cardiovascular events. The study is observational and includes patients undergoing CABG surgery. Participants will be enrolled during their preoperative evaluation. A peripheral blood sample will be taken within 24 hours before the CABG surgery to measure Galectin-3 levels. Patients will then be followed daily during hospitalization and through three follow-up appointments after discharge, for a total follow-up period of 12 months. During the study, researchers will monitor whether participants develop atrial fibrillation within 7 days after surgery and assess other complications at 6 weeks. They will also track major cardiovascular events and changes in the hearts left atrium structure over 12 months. The study involves blood sample collection, health assessments during hospital stay, and scheduled follow-up visits to gather comprehensive outcome data.
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Camptodactyly-Arthropathy-Coxa Vara-Pericarditis CACP syndrome is a rare inherited disorder caused by mutations in the PRG4 gene. It is characterized by the combination of camptodactyly bent fingers or toes, joint problems without inflammation, and deformity of the hip bone, sometimes also involving heart and lung issues. The syndrome shows variable symptoms and may be underdiagnosed due to its rarity and resemblance to juvenile arthritis. This European multicenter study aims to collect detailed clinical, genetic, and therapeutic data to better understand the diseases characteristics and progression in children diagnosed with CACP syndrome. Participants are children diagnosed with CACP syndrome confirmed by genetic testing who were diagnosed between 2005 and early 2026. The study involves regular clinical visits approximately every six months to monitor symptoms, joint function, and possible complications like pericarditis. Imaging and lab tests are done every 1 to 2 years or as needed. No specific drug treatment is available, and the study focuses on observing the disease course, treatment approaches, and genotype-phenotype relationships over a 10-year period. Throughout the study, researchers will collect epidemiological and clinical information, including disease incidence, geographic and ethnic distribution, symptom progression, and treatment outcomes. Patient disability, pain levels, and well-being will be tracked using questionnaires. The study will also document any misdiagnoses before confirmation of CACP. Monitoring adverse events related to treatments used will be included. This long-term observation will help improve understanding and management of CACP syndrome in affected children.
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This research aims to evaluate the knowledge and technical skills of emergency medicine advanced practice providers APPs in performing cardiac point-of-care ultrasound POCUS through a simulation and just-in-time training pathway. The goal is to determine the feasibility, acceptability, and usability of this ultrasound training program and develop a standardized model that could help improve POCUS clinical performance and patient care. Participants will undergo a cardiac POCUS simulation session followed by a hands-on observed structured clinical skill exam led by ultrasound-trained faculty. After training, APPs will perform POCUS during standard clinical care under the supervision of emergency medicine attending physicians. The study includes surveys and interviews before training, immediately after, and six months later to assess the programs impact. Throughout the study, participants will complete knowledge and skill assessments as well as surveys and semi-structured interviews to evaluate feasibility, acceptability, and appropriateness of the training. Researchers will measure outcomes such as the educational and clinical impact of the training on POCUS use, image quality, diagnostic accuracy, and related clinical metrics over 1 to 2 years at each study site. The total participation duration varies with ongoing staffing needs and training assessments.
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This research investigates the prevention of recurrent pericarditis in patients who have a history of this condition and have been treated with an IL-1 blocker for at least 12 months. The study is a multi-center, randomized, double-blind, placebo-controlled Phase-3 trial aiming to evaluate whether patients remain free of pericarditis recurrence while receiving the study drug CardiolRx. Participants will be randomly assigned to receive either CardiolRx or a matching placebo. The treatment begins 10 to 16 days before the last scheduled dose of the IL-1 blocker and continues for 24 weeks. CardiolRx or placebo is administered orally twice daily with food, starting at 5 mgkg twice daily for the first few doses, increasing to 7.5 mgkg, and then to 10 mgkg twice daily through Week 24. Throughout the study, participants will undergo various assessments including physical exams, vital signs, ECGs, blood tests for inflammation markers, and pain evaluations using a numerical rating scale. Safety monitoring includes recording adverse events and concomitant medications at all visits. After 24 weeks of treatment, a final efficacy assessment occurs, followed by a virtual safety follow-up visit four weeks after the last dose. The primary outcome is the recurrence of pericarditis during the 24 weeks of treatment.
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Myocarditis and pericarditis are inflammatory diseases of the heart muscle and surrounding tissue, which can occur due to various causes including vaccines. This research investigates cases of inflammatory heart disease that developed after receiving COVID-19 vaccines, focusing on symptoms like chest pain and shortness of breath that appear within 2 to 10 days post-vaccination, often after the second dose. The study includes both a retrospective review and a prospective case-control design to better understand this condition. The study has two parts first, a retrospective chart review to establish a database of patients previously diagnosed with vaccine-related myocarditis or pericarditis. Second, a prospective case-control study will enroll patients who develop symptoms within 42 days of COVID-19 vaccination, along with controls who have been vaccinated but did not develop symptoms. Clinical information and blood samples will be collected at baseline and during a follow-up visit 4 to 12 weeks later, with ongoing telephone interviews at 6 months, 12 months, and yearly up to 4 years. Participants will undergo clinical assessments and blood tests at initial and follow-up visits, and complete quality-of-life questionnaires. Researchers will track serious cardiac events, recurrence of symptoms, arrhythmias, cardiovascular mortality, and overall quality of life over the study period. The long-term follow-up via telephone interviews and record reviews will help monitor the participants clinical status and health outcomes for up to four years.
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Researchers are working to adapt and pilot the WHO Package of Essential Non-communicable Diseases PEN Plus intervention in Zambia to address the growing burden of complex chronic diseases such as diabetes, hypertension, and cancer. The study focuses on improving management of these diseases at first-level hospitals using an implementation framework designed to tailor interventions locally and prepare for national scale-up. This effort responds to increasing cases and insufficient primary care capacity in Zambia. The study involves adapting the PEN-Plus model through stakeholder engagement, training of frontline health workers, and establishing PEN-Plus clinics at selected peri-urban and rural hospitals. These clinics will provide care led by mid-level providers supported by specialists. The intervention includes supportive treatment, provision of necessary drugs and equipment, and integration with existing health information systems. The project will also develop national policies and operational plans to enable wider implementation. Participants are patients with chronic non-communicable diseases receiving care at first-level hospitals. Researchers will monitor implementation outcomes such as patient enrollment, care quality, and cost, as well as training outcomes for healthcare providers. Data collection includes routine visits and patient records integrated with national systems. The primary outcome measures the increase in patients diagnosed and managed according to WHO PEN-Plus guidelines over six years, with ongoing monitoring and evaluation of the program impact.
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Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases ICARDs include heart involvement in connective tissue diseases, vasculitis, and primary inflammatory heart conditions affecting all heart layers. These diseases increase the risk of serious heart problems and death beyond traditional risk factors, with diverse symptoms making diagnosis and prognosis difficult. Multimodality cardiovascular imaging plays a key role in identifying and understanding these conditions, but its full diagnostic and prognostic value in ICARDs remains unclear. The study observes patients suspected or diagnosed with ICARDs who are referred for cardiovascular magnetic resonance CMR andor cardiac positron emission tomography PET scans. It collects data from multiple centers internationally to assess the prevalence of confirmed heart involvement. This study does not test treatments but focuses on imaging to better detect and classify these diseases and gather information on treatment approaches and their outcomes. Participants undergo imaging exams such as CMR and PET, with follow-up assessments lasting about one year. Researchers will collect baseline data, monitor clinical outcomes including mortality, hospitalizations, and disease remission. The study aims to evaluate the diagnostic and prognostic usefulness of imaging, with findings that may influence future guidelines and treatment strategies for heart involvement in ICARDs.
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