The Clinical Cardiovascular Research Center (CCRC) ECG Core Laborarorty (ECL) has been involved in quantitative electrocardiology research for over 30 years.  The main focus of this research is on ventricular arrhythmias and ventricular repolarization analyses.  The ECL conducts analysis of all types of ECG recordings including standard 12-lead ECG, signal-averaged ECG (SAECG), digital high resolution ECG, long-term ECG patch signals, and long-term 24-hour Holter recordings. 

 

Over several years of conducting NIH and industry sponsored large clinical studies and trials, the ECL has developed expertise in the central coordination and analysis of ECG recordings.

 

 Our ECG is actively involved in various clinical and animal ECG studies requiring central management of ECG data acquisition, central reading and analysis of ECGs in various technical forms. The analysis of paper-copy and digitla ECGs, with particular emphasis on QT interval evaluation, is our routine activity related to specific research or drug-safety oriented projects. In the current era of digital ECG technology, we are fully operational managing data acquisition  utilizing the state-of-the-art methodologies.

The CCRC-ECL has served as central ECG, Holter, and SAECG core laboratory for several large NIH, EPA, HEI sponsored studies including:

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• Long QT Syndrome:  Population, Genetic and Cardiac Studies

• Genetics, Mechanisms and Clinical Phenotypes of Arrhythmogenic Cardiomyopathy  

• Multicenter Postcoronary Risk Stratification Program

• Multicenter Study of Silent Myocardial Ischemia

• Thrombogenic Factors and Recurrent Coronary Events

• Effect of air pollution on ECG parameters in animal, human exposure,  and epidemiological studies

• Effect of Raloxifen on Repolarization

• Effect of Flecainide on Repolarization in LQT3 Patients

• Analysis of ECG changes in LQT2 Patients

• Ranolazine ICD Trial

• Interest of IKr-related Abnormalities of ECGs to Improve Drug-safety Evaluation

• Risk-Stratification of Patients with the Long QT Syndrome (LQTS) based on Holter Recordings

• QT-RR Dynamic Coupling in Patients with the Long QT Syndrome

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as well as corporate sponsored studies including:

• Multicenter Diltiazem Postinfarction Trial (Marion Laboratories)

• Multicenter Automatic Defibrillator Implantation Trial (CPI/Guidant)

• Repolarization Analysis in Diphenhydramine Overdose Patients (Warner Lambert)

• Intercity Digital Electrocardiology Alliance (Burdick)

• Repolarization Analysis in Patients Treated with Mibefradil (Hoffman LaRoche)

• Multicenter Automatic Defibrillator Implantation Trial II (CPI/Guidant)

• Dynamic Aspects of repolarization (Ela Medical, Sanofi-Synthelabo)

• Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients (Guidant/Boston Scientific)

• Study of the Wearable Defibrillator:  In Advanced Heart Failure Patients (LifeCor)

• Wearable Cardiac Defibrillator Study in Hemodialysis Study (LifeCor)

• Ranolazine in LQT3 Patients (Gilead Sciences)

• LQT3 Registry (Gilead Sciences)

• Multicenter Automatic Defibrillator Implantation Trial: Chemotherapy-Induced Cardiomyopathy (Guidant/Boston Scientific)

• A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (Gilead Sciences)

• A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects with Paroxysmal Atrial Fibrillation (Gilead Sciences)

• An Open-label Study to Evaluate the Effect of Single Dose GS-6615 on QT, Safety and Tolerability in Subjects with Long QT-3 Syndrome (Gilead Sciences)

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The CCRC-ECL is equipped with a large set of ECG recorders and analyzer including digital devices from all the major american and European companies. The orgis fully prepared to conduct computer analyses of various high-resolution and long-term digital ECG recordings. We have in operation computer programs which interpret various aspects of ECG changes, including not only repolarization analysis in standard and long-term recordings,as described before but also P-wave, QRS signal-averaging, and heart rate variability analyses.

The above ECG-analytic facilities are merged with a central computer clinical data management that has been developed and validated over last 20 years.