Biotronik has announced the start of its prospective multicentre PARCADIA study. The study aims to identify risk factors that can help predict appropriate implantable cardioverter defibrillator ICD interventions in patients with ischaemic cardiomyopathy who have received an ICD for primary prevention according to the current European Society of Cardiology (ESC) guidelines. The first patient has now been enrolled in the Isala Clinics, Zwolle, The Netherlands.
“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,” said 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.”
Current ESC guidelines indicate ICDs for primary prevention for patients who have a left ventricular ejection fraction (LVEF) of less than 35%. 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.
“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,” said 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.”
The primary objective of the PARCADIA study is to explore the potential of myocardial scar, assessed by MRI, as a predictor for appropriate ICD intervention. Myocardial scar is an important substrate for developing ventricular arrhythmias in ischaemic cardiomyopathy. “Late Gadolinium Enhanced Cardiac MRI has a very high sensitivity to detect the amount of myocardial scar and might thus be useful in the prediction of future arrhythmic events,” said Elvan.
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 PARCADIA study is a prospective, non-randomised, multicentre clinical investigation of 200 eligible patients performed in four centres in The Netherlands. All patients in the study are identified with ischaemic 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 expected. Final study results are expected in 2017.