Clinical Trial Services
ECG and Arrhythmia Core Laboratory
All tracings in the lab are read by board-certified cardiologists and electrophysiologists with expertise in waveform and arrhythmia analysis. The lab also specializes in analyzing Holter/loop recordings in atrial fibrillation therapeutic trials.
HCRI’s ECG and Arrhythmia Core Laboratory has extensive experience in evaluation of ECGs, ambulatory monitoring tracings and device electrocardiogram analysis. Since 1997, the ECG Core Laboratory has provided ECG analytical services for more than 100 clinical trials of medical devices, drugs, and radiation therapies including SAFER, START, SIRIUS, CADILLAC, FRACTAL and PROSPECT.
The core lab is proud to have an important role in novel interventional cardiology device trials involving the treatment of arrhythmias as well as coronary artery disease. The Food and Drug Administration recently approved several devices tested by the laboratory.
The laboratory is responsive and dedicated to supporting complex projects with aggressive timelines. A full time cardiologist is present on site and Harvard Medical School cardiologists are regularly utilized to provide additional expertise and resources for quick turnaround on ECG reviews.
The specific parameters interpreted in the ECG laboratory analyses are rhythm, conduction abnormality, interval prolongation (PR, QRS, QT), major ST-T abnormalities, and Q wave myocardial infarction.
Specialties of the laboratory include:
The core lab is proud to have an important role in novel interventional cardiology device trials involving the treatment of arrhythmias as well as coronary artery disease. The Food and Drug Administration recently approved several devices tested by the laboratory.
The laboratory is responsive and dedicated to supporting complex projects with aggressive timelines. A full time cardiologist is present on site and Harvard Medical School cardiologists are regularly utilized to provide additional expertise and resources for quick turnaround on ECG reviews.
The specific parameters interpreted in the ECG laboratory analyses are rhythm, conduction abnormality, interval prolongation (PR, QRS, QT), major ST-T abnormalities, and Q wave myocardial infarction.
Specialties of the laboratory include:
- Ischemia monitoring: The core lab is experienced with identification of ECG-derived clinical endpoints. Board-certified cardiologists and electrophysiologists perform all analysis. The laboratory has unique expertise with differentiation of ischemic from non-ischemic ECG changes and has used this knowledge in acute myocarditis trials.
- Arrhythmia monitoring: The core lab has a full-time staff of clinical electrophysiologists that have been actively involved in defining clinical endpoints for catheter ablation trials of standard and novel therapies.
- Device electrogram analysis: Analysis of device electrograms (pacemaker, ICD, implantable loop recorders) is performed by cardiac electrophysiologists.
- ECG overreading: The group has extensive experience with overreading ECG data acquired by other core laboratories or sites as part of clinical trials.
- Trial design consultation is available with the core lab directors.
- Coordination of non-ECG core lab services: The core lab director is able to assist in the recruitment of other core lab services including imaging.
