Vercelli

This research aims to improve understanding of rare autoinflammatory diseases (AID), which cause repeated inflammatory episodes without infection or cancer. The study focuses on hereditary periodic syndromes (monogenic AID) caused by gene mutations, as well as related polygenic or multifactorial AID like Behcet's disease, Still disease, Schnitzler's disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, spondyloarthritis, and Castleman disease. The goal is to gather detailed clinical and therapeutic data to expand knowledge of these rare conditions, which are often difficult to diagnose outside specialized centers. Participants will be enrolled in the AIDA international registry, which uses a secure online platform to collect retrospective and prospective information. Data collected include demographics, genetics, clinical features, laboratory and radiologic results, treatments, and socioeconomic impact. The registry covers multiple specific AID types and will track patients over at least 10 years through routine clinical visits usually every 3-6 months. The platform supports data sharing and analysis to identify disease patterns, treatment responses, and long-term outcomes. During the study, patients' medical records will be regularly updated with clinical and laboratory data. Researchers will analyze changes in patient numbers and disease characteristics over time. The registry also aims to foster international collaboration, improve early diagnosis, assess quality of life and socioeconomic effects, and support future research and clinical trials. Patient data privacy is maintained by using pseudonyms and complying with data protection laws throughout the study.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are developing and validating a natural language processing (NLP) tool called eCREAM_LM to interpret emergency department electronic medical records (EHRs) from adult patients. The goal is to extract important information from free-text notes to support clinical research and quality care assessments in emergency medicine across multiple languages. This retrospective cohort study collects data from 30 centers in various European countries, covering a three-year period from 2021 to 2023. The study involves training and fine-tuning the eCREAM_LM model using billions of medical texts and millions of free-text notes from participating hospitals. Physicians annotate thousands of clinical notes to create a virtual clinical report form (vCRF) for training. Validation is performed by comparing how well the model fills out the vCRF against expert physicians using a separate set of 1,000 clinical notes. Data are anonymized to protect patient privacy and combined into language-specific databases for analysis. Participants are adult patients who visited emergency departments during the specified period. Researchers evaluate the model's accuracy by measuring agreement between the model and clinicians in completing the vCRF within one month. The study uses Cohen's kappa statistic to assess concordance, aiming for a value over 0.75. There is no intervention or treatment given, as the study solely analyzes existing medical records to improve emergency care research tools.

Researchers are investigating the treatment of coronary in-stent restenosis (ISR), a condition where the artery narrows again after stent placement, despite advances in drug-eluting stents. This trial compares two methods of guiding percutaneous coronary intervention (PCI) for ISR: one using intracoronary optical coherence tomography (OCT) along with angiography, and the other using angiography alone. The goal is to understand whether OCT guidance improves acute PCI performance for ISR patients. Participants with ISR showing 70% to 99% narrowing in a vessel between 2.25 and 5.75 mm will be randomly assigned to two groups. The first group will have PCI guided by OCT and angiography, with OCT runs before and after PCI, and additional OCT imaging allowed during the procedure. The second group will have PCI guided only by angiography, but OCT imaging will still be performed before and after PCI without the operator seeing the OCT results to maintain blinding. Operators in both groups may use various approved tools and techniques during PCI as needed. During the study, patients will undergo imaging and PCI procedures with detailed documentation of the treatment plans and any changes after OCT review. Researchers will measure changes in artery cross-sectional area after PCI as the primary outcome. Safety and procedural details will be closely monitored. The total participation includes the PCI procedure and follow-up imaging to assess treatment effectiveness.

Researchers are evaluating a new diagnostic and treatment approach for patients with myocardial bridge (MB), a condition where a coronary artery is compressed during heartbeats. The study aims to compare a full-physiology approach, which uses detailed invasive tests to uncover the causes of heart ischemia, with a standard angiographic evaluation. This randomized, open-label trial seeks to improve diagnosis and personalize treatment plans for MB patients. Patients diagnosed with MB during coronary angiography will be randomly assigned to one of two groups. The full-physiology approach group will undergo comprehensive functional tests including measurements of artery pressure and flow, responses to medications like adenosine and dobutamine, and a provocative acetylcholine test to detect artery spasms. The standard approach group will receive a typical angiographic evaluation of the affected artery segment. Both procedures involve coronary angiography through radial or femoral access. Participants will be monitored for outcomes including significant angina and major adverse cardiac events over a one-year period. The study includes detailed physiological assessments during the initial procedure, continuous symptom and ECG monitoring, and follow-up to evaluate the effectiveness of the diagnostic strategies. Safety and event rates will be analyzed with statistical methods, including an interim analysis after six months for half of the participants.

Researchers are comparing two types of drug-coated balloons, Selution sirolimus coated balloon and SeQuent Please Neo paclitaxel coated balloon, for treating new coronary artery lesions in medium-small vessels measuring between 2.00 mm and 3.00 mm. The study aims to evaluate the angiographic outcomes, specifically the Net Gain in the treated area and Fractional Flow Reserve (FFR), over a 12-month follow-up period. This prospective, randomized, multicenter study focuses on patients with stable angina or stabilized acute coronary syndromes and involves only one lesion per patient, with specific inclusion criteria based on vessel size and lesion characteristics. Participants will be randomized 1:1 to receive either the sirolimus or paclitaxel coated balloon after successful lesion preparation. The study ensures treatment of other non-study lesions before the study lesion if present, with any necessary commercial devices. Follow-up includes phone calls at 1 and 6 months, and a mandatory angiographic and FFR assessment at 12 months at the same site as the initial procedure. Patients will receive dual anti-platelet therapy for at least one month following the procedure, then aspirin alone indefinitely, with adjustments if recent acute coronary syndrome or additional stents are involved. During the study, assessments include quantitative coronary angiography before and after the procedure and during follow-up, as well as FFR measurements at follow-up angiography. The researchers will monitor the treated vessel's condition and heart function, tracking safety and efficacy outcomes. The total study duration includes the initial procedure, follow-ups at 1 and 6 months by phone, and a 12-month angiographic follow-up, ensuring comprehensive evaluation of treatment outcomes and patient health over time.

Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the disease's natural history in real-world settings. This study aims to define and validate models that predict disease progression and response to treatment at any stage. The registry will also promote collaboration among amyloidosis experts and physicians across Italy involved in diagnosing and managing systemic amyloidosis. The study involves collecting data from patients diagnosed or suspected to have systemic or localized amyloidosis. An online registry tool will be established to share this data with healthcare providers, facilitating diagnosis and treatment decisions. This network will enable physicians to access diagnostic resources through the ARTC and support ongoing patient management. Participants will provide informed consent and have planned or ongoing follow-up at participating centers. Data collected includes information at diagnosis and during follow-up visits. The primary outcome is to establish an online data-sharing tool accessible to healthcare providers over a five-year period. This approach aims to improve understanding, collaboration, and care for patients with ATTR amyloidosis.