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

Abstract

a b s t r a c tBackground: The ability to identify peri-procedural complications or predict short and long-term adverse outcomes in patients undergoing cardiac or peripheral angiography is imperfect. Methods: In 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. Results: Data 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. Conclusions: The 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 (Clinical Trials.Gov # NCT00842868).

Single‐Molecule Counting of High‐Sensitivity Troponin I in Patients Referred for Diagnostic Angiography: Results From the CASABLANCA (Catheter Sampled Blood Archive in Cardiovascular Diseases) Study

“…The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure. The CASABLANCA study was a prospective, single‐center, investigator‐initiated, observational cohort study undertaken at Massachusetts General Hospital in Boston . Over a 3‐year period between September 2008 and November 2011, 1251 participants undergoing coronary and peripheral angiography with or without intervention were enrolled.…”

“…After informed consent was obtained, demographics, clinical characteristics, reason for referral for angiography, and angiographic results (based on the final report from the procedure) were noted at the time of the procedure. As previously reported, patients were mainly referred for evaluation of CAD (Table ) …”

“…Given these open questions, we examined the diagnostic and prognostic utility of hsTnI in 991 patients without acute MI referred for diagnostic coronary angiography for various indications who were enrolled in the CASABLANCA (Catheter Sampled Blood Archive in Cardiovascular Diseases) study (http://ClinicalTrials.Gov identifier NCT00842868) . We hypothesized that hsTnI concentrations would correlate with prevalent CAD and predict incident cardiovascular events and mortality in patients with obstructive and nonobstructive CAD.…”

A clinical and proteomics approach to predict the presence of obstructive peripheral arterial disease: From the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) Study

“…The CASABLANCA study was a prospective, single‐center, investigator‐initiated, observational cohort study performed at Massachusetts General Hospital in Boston; 1251 subjects undergoing coronary and peripheral angiography ±intervention between 2008 and 2011 were enrolled …”

“…We previously demonstrated the utility of combining clinical variables with machine learning supported proteomics for diagnosis and prognosis of coronary artery disease (CAD) . Accordingly, we sought to identify clinical and biomarker predictors of clinically significant PAD in an at‐risk population of subjects enrolled in the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study undergoing peripheral angiography . We hypothesized that the combination of biomarkers and clinical risk factors might increase the accuracy of predicting clinically significant PAD.…”