The Laboratory of Clinical Research in Brain and Cardiovascular Injury designs, coordinates and executes multicenter randomized controlled clinical studies to assess effectiveness of innovative treatments in the setting of critical care medicine and cardiovascular diseases. These studies are leveraged to collect blood and tissue samples in a certified biological bank. The primary objective of the Laboratory, using the biobank, is to identify "biomarkers" circulating in the blood, which inform on disease severity and progression, to optimize individualized treatment development.
NEW THERAPEUTIC APPROACHES FOR CRITICALLY ILL PATIENTS: SEPTIC SHOCK
Septic shock is a life-threatening condition caused by a severe infection that triggers an uncontrolled inflammatory response, leading to widespread tissue damage, organ failure, and a high risk of mortality. Despite advances in critical care, effective therapeutic strategies remain a major challenge. The primary objective of the multicentre ALBIOSS-BALANCED trial is to evaluate, in patients with septic shock, whether (1) the administration of albumin in addition to crystalloids, compared to the use of crystalloid alone, reduces mortality at 90 days; (2) the use of balanced crystalloid solutions reduces 90-day mortality or the incidence of acute renal failure, compared to the use of physiological solution. The present study also aims to create a biobank of plasma and urine samples to study circulating and urinary markers that can aid in diagnosis and prognosis and can clarify the response to treatments applied during septic shock.
LONG TERM THERAPY AFTER ACUTE MYOCARDIAL INFARCTION
Beta-blocking drugs have been used in clinical practice for decades in the treatment of acute myocardial infarction although there is no evidence of their beneficial effect when used chronically in patients without left ventricular dysfunction. REBOOT, a pragmatic, multicentre, prospective, randomized study, aims to evaluate the benefits of prolonged beta-blocker therapy in patients discharged after acute myocardial infarction, with preserved ventricular function. The research project is promoted by the "Centro de Investigaciones Cardiovasculares, CNIC" of Madrid, and our Laboratory is responsible for the scientific coordination of the Italian Cardiology network.
TREATMENT OF FAMILIAL CEREBRAL ANGIOMAS
The Treat_CCM study was a Phase 2 clinical trial designed to evaluate the efficacy, feasibility, and safety of the beta-blocking drug propranolol in patients with familial cerebral cavernous malformations (FCCM). Cerebral cavernous malformations are clusters of abnormally enlarged, thin-walled blood vessels in the brain that can lead to bleeding, seizures, and neurological deficits. Preclinical and observational studies suggest that propranolol may help reduce lesion progression and clinical events in FCCM by acting on vascular stability and permeability. The study has shown that propranolol is safe and potentially beneficial in fCCM. In addition, the data collected during the study has allowed for the study of biomarkers in fCCM, gaining new insights into different aspects of the disease. Additionally, efforts are underway to secure funding for a Phase 3 trial, which will further investigate propranolol’s potential as a therapeutic option to improve patient outcomes and reduce the need for invasive interventions.
PERSONALIZED CARE PATHWAYS
The iCARE4CVD project is an initiative aimed at improving the prevention, detection, and management of cardiovascular diseases through innovative digital health solutions. The project focuses on creating personalized care pathways using advanced technologies such as artificial intelligence and wearable devices to monitor and collect data on the patient’s vital parameters. By integrating these technologies into healthcare systems, iCARE4CVD seeks to enhance patient outcomes, optimize treatment plans, and support healthcare professionals in making more informed decisions, ultimately reducing the burden of cardiovascular diseases on individuals and healthcare systems.
NOVEL APPROACH TO PERSONALIZED CARDIOVASCULAR RISK ASSESSMENT
The CVRiskIT study is a research initiative focused on developing and validating an innovative tool for assessing cardiovascular risk conducted in collaboration with the Laboratory of Cardiovascular Prevention. By integrating various health data, such as lifestyle factors, biomarkers, and medical history, CVRiskIT aims to create a more accurate and personalized method for predicting the likelihood of cardiovascular events. The study seeks to improve early detection, prevention strategies, and clinical decision-making, ultimately reducing the impact of cardiovascular diseases on individuals and healthcare systems.
ARGON VENTILATION FOR NEUROPROTECTION IN CARDIAC ARREST
The CPAr Phase 2 study is designed to evaluate the safety and efficacy of lung ventilation with a gas mixture of Argon and Oxygen in comatose patients following out-of-hospital cardiac arrest. Preclinical studies indicate that Argon has neuroprotective and cardioprotective properties, helping to reduce cell death and tissue damage after brain and heart hypoxic-ischemic injury. By assessing its potential to mitigate neuronal and myocardial damage, this study aims to determine whether Argon ventilation can improve clinical outcomes and recovery in post-cardiac arrest patients.
PREVENTING CARDIOVASCULAR COLLAPSE DURING URGENT INTUBATION
The PREVENTION study is a randomized controlled trial investigating whether the pre-emptive infusion of norepinephrine can reduce the incidence of cardiovascular collapse in critically ill patients undergoing urgent tracheal intubation. Given the high risk of hemodynamic instability during intubation and the lack of effective preventive strategies, this study aims to determine whether proactive vasopressor administration can improve patient outcomes by mitigating post-intubation hypotension and reducing associated morbidity and mortality.
International Consensus on Cardiopulmonary Resuscitation.
