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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

All Genders
38 locations
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Actively Recruiting

Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation AF who have multiple long-term health conditions. This study aims to compare the iABC approach with usual clinical care to see if it leads to better clinical outcomes and quality of life. The iABC strategy focuses on three key areas preventing stroke with appropriate anticoagulation, improving symptom control, and optimizing treatment of related heart and other health conditions. The trial is conducted across several European countries including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. The study is designed as a cluster randomized trial where participating centers are assigned either to implement the iABC platform or continue their usual care practices. The iABC platform combines an educational program, a healthy diet and physical activity plan, guideline-based medication management, and regular patient reassessments. Doctors using iABC can monitor patient data and provide personalized advice on treatments and lifestyle throughout the study. Centers in the control group will manage patients according to their local standard care guidelines. Participants will be followed for at least 12 months to assess the impact of iABC on outcomes such as unplanned hospitalizations, stroke and cardiovascular events, physical activity levels, patient engagement, and medication adherence. The study includes regular data collection to monitor these factors and assess adherence to the iABC care pathway. This approach aims to provide clear evidence about whether a holistic, integrated care model can improve health and quality of life in older adults with AF and multiple health issues.

Age: 65Years +All GendersPhase Not Applicable
50 locations
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Actively Recruiting

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Age: 18Years +All GendersPhase 4
54 locations