Clinical trials

11

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)

Consenting patients with end-stage heart failure that are implanted with/candidates for implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist Device (VAD) will be enrolled in the study. Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it interacts with the support device as well as the effect of antithrombotic drugs. From these data, it will be possible to derive the mechanisms triggering post-implant thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.

Participants needed: 60
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: May 15, 2025Locations: 1Duration: 2 Years
Eligibility criteria

All consenting patients candidates for short-term (Impella, ECMO) or durable (LV... [+1]

Status: Recruiting

GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.

This study aims to answer multiple unsolved questions in the field of arrhythmic myocarditis. * Improving the diagnostic work-up. While endomyocardial biopsy (EMB) and cardiac magnetic resonance (CMR) constitute the gold standard diagnostic techniques for myocarditis, the role of genetic testing is still unclear. Identifying the subset of patients with CGVs, will contribute to justifying the application of genetic testing in myocarditis. * Generating models for risk prediction. Outcomes and arrhythmic risk stratification remain uncertain for myocarditis. Based on an advanced multimodal work-up, multiparametric risk scores may be created and subsequently validated, in order to predict the arrhythmic risk of specific myocarditis, especially in the case of CGVs. * Identifying disease-specific and genotype-specific signatures. Genotype-phenotype associations are expected to benefit from a multimodal and multiparametric approach, in order to allow etiology-specific features in arrhythmic myocarditis. Most of the current signatures are limited to combined EMB-CMR studies. Signatures would likely benefit from implementing additional parameters, including arrhythmia features and myocardial inflammatory status. * Tailoring treatment strategies. Transcriptional analysis will identify overexpressed genes associated with myocarditis and arrhythmias, representing a possible therapeutic target. A multimodal and multidisciplinary model will integrate phenotype, genotype, and transcriptional profile for a personalized treatment.

Participants needed: 262
Trial details
Age: 10-80Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Mar 21, 2025Locations: 1
Eligibility criteria

Diagnosis of myocarditis proven by EMB (ESC criteria) and/or CMR (updated Lake L... [+5]

Obstructive coronary artery disease, or lack of coronary angiography/computed to... [+1]

Status: Recruiting

Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer

The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.

Participants needed: 472
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Dec 17, 2024Locations: 4
Eligibility criteria

Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segme... [+1]

Age < then 18 years at the moment of surgery [+1]

Status: Recruiting

Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers

The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy. There are no risks for the patients, as this is a retrospective data collection.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Nov 29, 2024Locations: 6
Eligibility criteria

Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (an... [+2]

Age <18 years old at the moment of surgery

Status: Recruiting

Robotic Assisted Major Lung Resection in Elderly Patients

The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers. There are no risks for the patients, as this is a retrospective data collection.

Participants needed: 386
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Nov 27, 2024Locations: 2
Eligibility criteria

Age >18 years at the moment of surgery [+4]

Age < 18 years at the moment of surgery [+1]

Status: Recruiting

The Lymphocytic Infiltrate of Lung Tumors.

The study is configured as a monocentric observational transversal biological study. The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC). The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Nov 29, 2024Locations: 1
Eligibility criteria

Ability to provide informed consent; [+2]

Previous chemotherapy for any cancer within the last 6 months; [+2]

Status: Recruiting

Prevention of Smoking Related Diseases

This is a prospective, observational, monocentric study. This study wants to test if among a smoking cessation intervention, behavioural counselling by video session is related to higher compliance and higher success rate than standard smoking cessation activity (face to face counselling).

Participants needed: 189
Trial details
Age: 50+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Nov 29, 2024Locations: 1
Eligibility criteria

Strong smokers (pack years >= 20) [+2]

Not having plans to quit smoking

Status: Recruiting

Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.

The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.

Participants needed: 2,840
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Scientific Institute San RaffaeleUpdated: Oct 3, 2024Locations: 1
Eligibility criteria

Age >= 50 years old [+5]

Previous or concurrent neoplastic disease, excluding skin cancers [+12]

Status: Recruiting

Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.

Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the myocardium. The main identified forms include dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy (RCM), and arrhythmogenic cardiomyopathy proper (ACM). More recently, further forms of cardiomyopathy have been described, less common and not uniquely classifiable, including: uncompressed myocardium (LVNC), peripartum cardiomyopathy (PPCM), structural correlates of arrhythmogenic mitral valve prolapse (AMVP), Anderson-Fabry disease (AFD), NICM associated with multi- system neuromuscular or autoimmune diseases, lysosomal diseases, glycogenosis, mitochondrial cytopathies and canal diseases with structural substrates. Finally, there are "overlap" forms, characterized by the sharing in the same subject of characteristic aspects of two or more of the above- mentioned diseases; and of the "undefined" forms, which to date do not reach the diagnostic criteria for any of the above-mentioned diseases. To the best of current knowledge, there are two points discovered in scientific research, namely the description of the arrhythmogenic and "inflammatory" phenotypes in a broad sense, which are summarized here with the acronym AINICM. In detail: 1. Arrhythmic manifestations account for the arrhythmogenic component of AINICM, which is not limited to ACM proper. In fact, most of the above diseases have a non-arrhythmic clinical presentation and a prevailing tendency to evolve towards a picture of cardiovascular decompensation. Although sudden arrhythmic death has been described throughout the spectrum of AINICM, early arrhythmic manifestations of such diseases have an unknown prevalence, an uncertain association with different disease genotypes and phenotypes, and still uncertain predictivity of long-term arrhythmic risk. At the same time, optimal diagnostic and therapeutic pathways in arrhythmias associated with AINICM are still being studied. 2. Myocardial inflammation (M-Infl) accounts for the inflammatory component of AINICM, and has recently been described in association with many AINICM on a genetic basis, including undefined and arrhythmic forms. The data is of high interest not only in the diagnostic, but also in prognostic and therapeutic field. In fact, on the one hand the presence of M-Infl seems to have a physio- pathological role in AINICM; on the other, as already known in myocarditis, the optimal therapeutic paths of arrhythmias may differ in patients with and without M-Infl; in particular, also in the light of the preliminary data available in adult and paediatric AINICM, the inflammatory forms are expected to respond better to immunosuppressive therapy, the arrhythmogenic ones to an ablative therapy with frequent need of implantation of cardiac devices. Based on the clinical presentation, NICM patients will be divided into arrhythmic (AINICM) and non-arrhythmic patients as study and control groups , respectively. The AINICM group will include presentation with ventricular fibrillation (VF), either sustained or non-sustained ventricular tachycardia (VT; NSVT), frequent premature ventricular complexes (PVC), supraventricular arrhythmias (SVA) and bradyarrhythmias (BA). Clinical presentations other than arrhythmic, including chest pain and heart failure, will define the control group. In parallel, as shown in Figure 1, patients with any evidence of M-Infl will be compared with those showing no signs of M-Infl.

Participants needed: 15,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Sep 23, 2024Locations: 1Duration: 30 Years
Eligibility criteria

Written informed consent. For pediatric patients, consent will be obtained by pa... [+1]

Absent informed consent. [+3]

Status: Recruiting

Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

Participants needed: 20
Trial details
Age: 0-17Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Sep 19, 2024Locations: 1Duration: 30 Years
Eligibility criteria

Written informed consent. [+3]

Absence of written informed consent. [+1]

Status: Recruiting

Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations. 1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation. 2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined. 3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis. 4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment. 5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Scientific Institute San RaffaeleUpdated: Sep 19, 2024Locations: 1Duration: 10 Years
Eligibility criteria

Written informed consent. [+3]

Absence of written informed consent. [+1]