Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.

What this Trial Is About

Researchers are conducting a prospective study to observe patients who are suspected of having cardiovascular events related to immune checkpoint inhibitor treatments used in cancer care. This study aims to describe patient characteristics, diagnostic procedures, and outcomes after a multidisciplinary review. It focuses on complications such as heart failure, atherosclerosis-related events, Tako Tsubo syndrome, arrhythmias, pericarditis, and myocarditis occurring during treatment with anti-PD1, anti-PDL1, or anti-CTLA4 immune checkpoint inhibitors. The study involves patients referred to a specialized cardio-oncology unit for evaluation of these suspected immune-related cardiovascular complications. There is no active intervention or treatment assigned for research purposes; instead, patients are observed and assessed as part of their clinical care. This longitudinal, single-center cohort study follows patients over time to document their cardiovascular health and any major cardiovascular events occurring within 12 months. Participants undergo various investigations, diagnostic assessments, and multidisciplinary evaluations to determine their condition and outcomes. The main outcome measured is the occurrence of major cardiovascular events within a year. The study tracks patient progress through routine clinical visits and records data regarding their cardiovascular status. Participation duration and follow-up extend over at least 12 months to monitor outcomes and safety under usual care conditions.

Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors