Provision of these services normally implies the in-house execution of software normally licensed to ECG core labs which require study-specific procedures, to include the design of the study protocol, a statistical analysis plan, and the redaction of the final report.
An example of External Support would be for a Holter-bin, a method typically applied to determine the effect of compounds that produce significant heart-rate changes. The AMPS WinAtrec continuous ECG software product processes this method and allows for the assessment of drug-induced modifications (of either the QT intervals but also of other standard ECG parameters) without the need to apply any heart-correction modeling.
WinAtrec was originally designed and introduced in the literature by the group of Philippe Coumel at the Lariboisiere Hospital in Paris (with the noteworthy contribution of Dr. Maison-Blanche and of AMPS Chief Scientist, Dr. Fabio Badilini). Initial use came within the pharmaceutical arena in 2003 as part of the dossier of the so called Alfusozin study (Sanofi).
Another example of External Support would be the assessment of repolarization morphology available through a dedicated CalECG analysis module. This module automatically computes a set of standard indexes related to the energy (area under the curve) of the post-QRS segment of the ECG waveform (for example, the time where 50% of the repolarization phase has been cumulated). In addition, a set of extra parameters are derived after the modeling with specialized curves known as Gaussian Mesa Function. These curves characterize the shape of the repolarization pattern through the quantification of the speed and magnitude of the ascending and the descending phases of the T wave. Finally, the repolarization package also includes the measurement of JTp/TpTe intervals, either as part of the CalECG embedded algorithm Bravo©, or computed using the public domain FDA open source library released in 2016.
Other additional services are available. These include a set of protocol-specific heart variability packages (implementing time or frequency domains methods and non-linear dynamic approaches), arrhythmia detection and beat-to-beat, or signal-averaged analyses from continuous ECG.
For further information or questions please contact: AMPS.Services@amps-llc.com