Design, methods, baseline characteristics and interim results of the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study

Abstract

BackgroundThe ability to identify peri-procedural complications or predict short and long-term adverse outcomes in patients undergoing cardiac or peripheral angiography is imperfect. MethodsIn a prospective single-center trial, 1251 subjects undergoing coronary and peripheral angiographic procedures ± intervention between 2008 and 2011 were enrolled to evaluate the use of cardiac and renal biomarkers for identifying peri-procedural events and predicting short and long-term events. Blood samples were taken immediately before and after the procedure. Clinical and angiographic characteristics were recorded. The primary end point is peri-procedural combined end point of major adverse cardiovascular events (MACE: death, myocardial infarction (MI), heart failure (HF), stroke, transient ischemic attack, peripheral arterial complication and cardiac arrhythmia). Secondary end points are assessed at peri-procedural, 30-day and 1-year, and include MACE and individual end points as well as renal complications including acute kidney injury (AKI) and worsening of chronic kidney disease. Extended follow-up of up to 6 years has also been completed. ResultsData from the first 491 patients have been obtained with 190 patients experiencing at least one MACE at 1-year follow-up with the following number of patients experiencing at least one specified event; 80 deaths, 39 MI, 73 HF, 21 neurological events, 37 peripheral arterial complications and 59 arrhythmias; additionally there were 55 patients with AKI. ConclusionsThe CASABLANCA study will examine the role of novel biomarkers and metabolomics for predicting a wide range of cardiovascular, neurologic, and renal complications in patients undergoing angiography. Full results are expected in the latter half of 2014 (ClinicalTrials.Gov # NCT00842868).