Electrocardiogram (ECG) Core Lab
Cleveland Clinic Cardiovascular Coordinating Center (C5)
Jean Cross, MSN, RN, Manager (216) 445-6396

The Purpose of an ECG Core Lab

Electrocardiographic parameters are a critical component of many clinical trials. An ECG Core Lab provides expert, objective, accurate and timely review of pre-specified, study-related ECG variables. This analysis can be utilized to identify ECG endpoints, safety endpoints, or clinical trial cases to be reviewed by a Clinical Events Committee for clinical endpoint determination.

ECG Core Lab Operation and Organization

The ECG Core Lab operates in collaboration with the Cleveland Clinic Cardiovascular Coordinating Center (C5) providing quantitative ECG analysis for single center and multicenter cardiovascular clinical trials. The ECG Core Lab is directed by Dr. Donald Underwood and Dr. Michael Lauer and managed by Jean Cross, MSN, RN. Dedicated ECG technicians who are trained in quantitative ECG analysis perform the ECG reviews. We operate in accordance with FDA regulations, with strict quality assurance and confidentiality standards. Quality assurance is an integral component of our processes. Expert Cardiologists oversee the ECG analysis and a minimum of 10% of ECG reviews are sent for QA review ensuring the accuracy and consistency of our results.

Our Experience

The ECG Core Lab has provided quantitative analysis of ECGs for multiple study timepoints in cardiovascular clinical trials enrolling thousands of patients in both single center and multicenter trials. Our most extensive experience is in the identification of Q waves and ST segment/T wave analysis. These data often provide the basis for the identification of cases for Clinical Event Committee review for myocardial infarction endpoint adjudication. Additional experience includes QT interval measurement for safety data as well as analysis of study specific ECG criteria.

For information, contact:
Jean Cross at (216) 445-6396