Prospective Multicenter PARCADIA Trial to Study Risk Stratification for ICD Interventions

 

October 12, 2012

October 12, 2012 — Biotronik last month announced the start of the prospective multicenter 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 was enrolled in Isala Clinics in 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,” explained Dr. Arif Elvan, coordinating clinical investigator at 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 percent. In addition, 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,” continued 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 magnetic resonance imaging (MRI), as a predictor for appropriate ICD intervention. Myocardial scar is an important substrate for developing ventricular arrhythmias in ischemic 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, nonrandomized, multicenter clinical investigation of 200 eligible patients performed in four centers in the Netherlands. All patients in the study are identified with ischemic cardiomyopathy indicated for de novo ICD implantation for primary prevention, according to ESC guidelines or local standards. Patients will be analyzed 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.

For more information: www.biotronik.com