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 20 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

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.

Age: 18Years +All Genders
1 location
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Actively Recruiting

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.

Age: 18Years +All Genders
1 location
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Actively Recruiting

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 drug's effects and safety.

Age: 18Years - 75YearsAll GendersPhase 2
18 locations
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Actively Recruiting

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 heart's 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.

Age: 18Years +All Genders
1 location
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Actively Recruiting

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 disease's 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.

Age: 0 - 18YearsAll Genders
10 locations
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Actively Recruiting

This research aims to understand how near-complete estrogen deprivation (NCED) therapy affects heart function in premenopausal women with breast cancer. The study compares heart changes in women receiving NCED therapy for high-risk hormone receptor-positive breast cancer to those in women with hormone receptor-negative breast cancer not receiving NCED. The main focus is on measuring changes in myocardial blood flow and heart stiffness over 24 months. Participants will undergo adenosine stress cardiac magnetic resonance imaging (CMR) tests, including myocardial blood flow measurements, at the start of the study and annually for two years. Additional tests include electrocardiograms at the beginning and after two years, coronary CT angiograms to assess artery plaque, blood draws for laboratory analysis, and quality of life surveys. The study monitors heart changes and breast cancer outcomes, with follow-up extending up to five years from baseline imaging. Throughout the study, participants will receive cardiac imaging stress tests and laboratory tests to track heart changes. Assessments include stress CMR myocardial blood flow, aortic stiffness, myocardial perfusion reserve, and coronary plaque burden. Researchers also develop models to predict heart blood flow deficits and monitor breast cancer survival and treatment changes. Safety and disease outcomes are followed annually after the two-year imaging period, with total participation lasting up to five years.

Age: 18Years - 55YearsFEMALEPhase Not Applicable
3 locations
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Actively Recruiting

Healthy Volunteer

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 program's 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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating CardiolRx in adults with recurrent pericarditis who have been stable on an IL-1 blocker treatment for at least 12 months and are planning to stop that treatment. This randomized, double-blind, placebo-controlled phase 3 trial aims to see if participants remain free from pericarditis recurrence while taking CardiolRx. The study is sponsored by Cardiol Therapeutics Inc. and involves monitoring the recurrence of pericarditis over a 24-week period. Participants will be randomly assigned to receive either CardiolRx or a matching placebo. The treatment is given orally twice daily with food, starting at 5 mg/kg twice daily for the first two days, then increasing to 7.5 mg/kg twice daily until day 10, and finally 10 mg/kg twice daily through week 24. The trial treatment begins 10 to 16 days before the last scheduled IL-1 blocker dose and continues for 24 weeks under double-blind conditions. During the study, participants will undergo regular assessments including pain scoring, physical examinations, vital signs, ECGs, and blood tests for inflammatory markers and safety monitoring. These evaluations occur at baseline, throughout treatment, and at the final 24-week visit, followed by a virtual safety follow-up 4 weeks after treatment ends. The main outcome measured is whether pericarditis recurs during the 24 weeks of treatment.

Age: 18Years +All GendersPhase 3
27 locations
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Actively Recruiting

Researchers are investigating recurrent pericarditis (RP), a condition that affects the heart's lining and can cause repeated episodes of inflammation. This study aims to explore the underlying causes of RP by testing for specific antibodies against the interleukin-1 receptor antagonist (IL-1RA) and measuring levels of soluble urokinase plasminogen activator receptor (suPAR). These tests may help distinguish between inflammatory and non-inflammatory forms of RP and improve understanding of how the disease works. The study also examines the relationship between these markers and signs of heart damage and inflammation, with the goal of guiding treatment decisions involving anakinra, a medication that blocks IL-1 pathways. Participants will be assessed based on whether they show signs of inflammation during RP episodes, such as fever or elevated blood markers, or if they have a non-inflammatory form without these signs. The study uses blood tests to measure IL-1RA antibodies and suPAR levels through established laboratory methods. Testing will occur during acute flare-ups and periods between episodes when possible, to track changes over time. Patients continue their usual care without changes influenced by the study. Throughout the study, participants will provide blood samples and undergo clinical evaluations to measure markers of inflammation and heart health. Researchers will track how antibody and suPAR levels relate to disease activity and recurrence over 24 months. The study is observational, focusing on collecting detailed biological and clinical data to better characterize RP subtypes and improve future treatment approaches. Safety and ongoing medical care are maintained throughout the study period.

Age: 18Years - 90YearsAll Genders
9 locations
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Actively Recruiting

Healthy Volunteer

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.

Age: 5Years +All Genders
1 location

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