Cardiac Safety Solutions

Cardiac safety is a key component of any drug or device clinical trial, with regulatory authorities requiring sponsors to demonstrate cardiac safety for all drugs. The collection and reporting of high-quality data is therefore essential to drive decisions across all phases of drug development.

We can help to assure the safety of all your clinical trial participants with our end-to-end cardiac safety solutions, including electrocardiography (ECG), event monitoring, blood pressure monitoring (BPM), long-term Holter monitoring, echocardiography (ECHO) and multi-gated acquisition scan (MUGA) studies.

Additionally, we can provide a range of cardiac monitoring devices, including both site-based equipment and patient centric, at-home devices for decentralised approaches to cardiac safety monitoring in clinical trials.

ICON supports all major cardiovascular testing modalities and use state-of-the-art technology to collect and transfer data efficiently and accurately, delivering high-quality results you can trust. Our broad team of over 120 medical professionals including medical doctors, cardiovascular research scientists, cardiac experts, cardiovascular electrophysiologists, TTM/Holter technicians, KOL expert consultants and board-certified cardiologists supports every aspect of your trial – from protocol design, statistical analysis, CSVR writing, expert report writing and communication with regulatory agencies.

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 including medical doctors and board-certified cardiologists.

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 centralised, data is processed into analysable sets, including requested systolic BP, diastolic BP, heart rate, mean arterial pressure, pulse pressure and rate pressure.

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 analyse these transmissions or address any issues with the patient by phone. 

Holter recordings, that can range from 24 to 48 to 72 hours and up to 7 days, are analysed by cardiovascular medical doctors, then reviewed and authorised 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.

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.