Cardioverter/Defibrillator and remote monitoring specialist company Biotronik has announced the start of the prospective multicentre PARCADIA study. The study aims to identify risk factors that can help predict appropriate ICD (implantable cardioverter defibrillator) interventions in patients with ischemic cardiomyopathy who have received an ICD for primary prevention according to the current ESC (European Society of Cardiology) guidelines. The first patient has now been enrolled in the Isala Clinics, Zwolle, the Netherlands.
Current ESC guidelines indicate ICDs for primary prevention for patients who have a left ventricular ejection fraction (LVEF) of less than 35%. Results from a previous study, the MADIT-II Trial, suggested that in addition to this, there is a need for a more effective risk-stratification method besides LVEF to identify patients that would benefit the most from an ICD.
The primary objective of the PARCADIA study is to explore the potential of myocardial scarring, assessed by MRI, as a predictor for appropriate ICD intervention. Myocardial scar tissue is an important substrate for developing ventricular arrhythmias in ischemic cardiomyopathy and might be useful in the prediction of future arrhythmic events, to which end late Gadolinium Enhanced Cardiac MRI, with its very high sensitivity to detect the extent of myocardial scar tissue will be used in this study.
Secondary objectives are to identify baseline risk factors that could help to design a risk score system based on the MRI data, electrocardiographical (24-hour Holter ECG) and biochemical (blood analyses) information.
The study is a prospective, non-randomised, multicenter clinical investigation of 200 eligible patients performed in four centres in the Netherlands. All patients in the study are identified with ischemic cardiomyopathy indicated for a “de novo” ICD implantation for primary prevention, according to European Society of Cardiology (ESC) guidelines or local standards. Patients will be analysed in two groups: one receiving appropriate ICD intervention and the other without an appropriate ICD intervention during Follow-up. In the first group a higher burden of myocardial scar is predicted, which in itself might indicate a clearer need for ICD implantation in such patients. Final study results are expected in 2017, so don’t hold your breath.
“Findings from the MADIT-II trial showed that only one-quarter of patients who had a myocardial infarction and got an ICD for primary prevention received an adequate shock therapy,” explained Dr. Arif Elvan, Coordinating Clinical Investigator, Isala Clinics. “With the PARCADIA study, we want to assess if there are additional parameters that could help us to better predict who should get an ICD and who will benefit most.”
“Most data regarding risk factors associated with appropriate ICD interventions comes from retrospective analysis of the major ICD trials with a primary goal of demonstrating ICD treatment survival benefit,” continued Dr. Elvan. “The PARCADIA study is designed to provide a clinical database to allow an explorative analysis of risk markers for more appropriate and effective ICD intervention.”
“With our extensive clinical study program, Biotronik consistently invests in research with the goal of discovering the best and most effective treatments. Biotronik’s comprehensive portfolio of clinical trials supports our quality solutions and is aimed at making a real difference in advancing effective, efficient, comprehensive healthcare delivery. We address important unanswered clinical questions and have the potential to impact therapy guidelines,” commented Christoph Böhmer, President International of Biotronik. “The PARCADIA study will help us define the best tools for predicting patients who would most benefit from receiving an ICD. Developing better, more accurate indication markers are in the best interests of patients, physicians and the health care system in general.”