Cardiac safety monitoring

Cardiac safety monitoring


A key component to help assure the safety of your compound

Cardiac safety monitoring


A key component to help assure the safety of your compound

As part of one of the world’s largest cardiac data networks, we support all major cardiovascular testing modalities for clinical trials including electrocardiography (ECG), event monitoring, blood pressure and Holter monitoring, as well as echocardiography (ECHO) and multi-gated acquisition scan (MUGA) testing. Additionally, we have a comprehensive portfolio of cardiac monitoring devices, including both site-based equipment and patient-centric, at-home devices for decentralized approaches to cardiac safety monitoring in clinical trials.

ECG Monitoring

ECG


We support cardiac safety monitoring by offering a full range of ECG reading methodologies.

  • Analyses typically include interval measurements, such as PR, RR, QRS, QT, QTcB and QTcF, QTcL and other QT correction formulas
  • Morphological and clinical ECG interpretation is provided by a team of experts such as medical doctors and board-certified cardiologists.

Cem ttm monitoring

Event monitoring - CEM, TTM


A variety of event monitors can be used for all phases of clinical drug development and device studies.

Drug development studies, such as those for atrial fibrillation, are typically designed for patients to call in daily and in case of a dysrhythmia event.

  • These transtelephonic transmissions may be monitored anywhere from 30 days to 6 months.
  • A team of experienced TTM technicians are available 24/7 to receive and analyze these transmissions or address any issues with the patient by phone.

BPM monitoring

Blood pressure monitoring (BPM)


Our blood pressure data upload system offers instant feedback to site personnel, even before data is transferred, enabling staff to make key decisions or perform additional procedures if needed..

  • Once centralized, data is processed into analyzable sets, including requested systolic BP, diastolic BP, heart rate, mean arterial pressure, pulse pressure and rate pressure.

Holter monitoring

Holter monitoring 


Holter recordings, that can range from 24 to 48 to 72 hours and up to 7 days, are analyzed by cardiovascular medical doctors, then reviewed and authorized by a board-certified cardiologist or electrophysiologist, if required.

  • Arrhythmia and ischemia reports include rate statistics, tachycardia or bradycardia episodes, supraventricular ectopy, ventricular ectopy, RR variability, ST deviation, pauses, rhythm profile, trends and waveform examples.
  • For Thorough QT (TQT) studies and other ECG-intensive trials, it is common practice to use Holter devices for continuous data acquisition, extracting 10-second segments for analysis either automatically or manually per protocol requirements.

Echo muga

ECHO/MUGA


Experienced physicians perform all ECHO analyses, including quantification of cardiac chamber size, ventricular mass, cardiac function, volume and wall thickness.

  • Display modes include 2-D, M-Mode, Doppler and Tissue Doppler.
  • Procedures are based on the American Society for Echocardiography guidelines, which are widely applied to clinical research and practice.

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