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Cardiac safety monitoring | Solutions | ICON plc
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The collection and reporting of high-quality data is therefore essential to drive decisions across all phases of drug development.</p><p>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.</p><p>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.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="62f17e8a-1c88-4ea1-b31f-5e84167febcf" class="icon-group icon-group--horizontal"> <div class="container-fluid container-fluid--xl"> <ul class="icon-group__items icon-group__items__columns-3"> <li class="icon-group__item--purple"> <div lang="en" class="icon-group__wrapper" > <i class="icon-quality"></i> <p class="mb-2 icons-large-text">20</p> <small>Years’ experience</small> </div> </li> <li class="icon-group__item--blue"> <div lang="en" class="icon-group__wrapper" > <i class="icon-healthcare"></i> <p class="mb-2 icons-large-text">1,091 </p> <small>Trials</small> </div> </li> <li class="icon-group__item--green-bright"> <div lang="en" class="icon-group__wrapper" > <i class="icon-approval"></i> <p class="mb-2 icons-large-text">82</p> <small>Drug approvals</small> </div> </li> </ul> </div> </div> <div id="9dcff35b-233e-4f57-a8ff-12332699d1c0"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> </h3> <div><p>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.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="839b7f01-21c7-4e71-941b-8b92907dd221"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> ECG: </h3> <div> <p>We support cardiac safety monitoring by offering a full range of ECG reading methodologies.</p> <ul> <li>Analyses typically include interval measurements, such as PR, RR, QRS, QT, QTcB and QTcF, QTcL and other QT correction formulas</li> <li>Morphological and clinical ECG interpretation is provided by a team of experts including medical doctors and board-certified cardiologists.</li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="6f2b6d90-beac-4f2d-9403-cc8fd27dfe5c"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Blood pressure monitoring (BPM) </h3> <div> <p>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.</p> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="3f565da6-9422-4ca3-9304-d6dfee266efb"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Event monitoring - CEM, TTM </h3> <div> <p>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.</p> <ul> <li>These transtelephonic transmissions may be monitored anywhere from 30 days to 6 months.</li> <li>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. </li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="cf0d06b8-21f5-474d-8703-2fa73907249b"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Holter monitoring </h3> <div> <p>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.</p> <ul> <li>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.</li> <li>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.</li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="411e0768-c3a7-43ce-bd52-f2377238fbd9"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> ECHO/MUGA </h3> <div> <p>Experienced physicians perform all ECHO analyses, including quantification of cardiac chamber size, ventricular mass, cardiac function, volume and wall thickness.</p> <ul> <li>Display modes include 2-D, M-Mode, Doppler and Tissue Doppler.</li> <li>Procedures are based on the American Society for Echocardiography guidelines, which are widely applied to clinical research and practice.</li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div><div id="9ff715de-3cc3-4616-af68-98592d0397c6"> <div> <div class="file file--with-thumbnail"> <div class="container-fluid container-fluid--xl"> <a href="https://www2.iconplc.com/Factsheet_Cardiac_Safety_Monitoring" target="_blank" title="Factsheet: Cardiac Safety Monitoring"> <span class="file__thumbnail"> <div> <div><div><img src="https://icon.widen.net/content/f57395f6-e287-4463-8e55-827586870b9d/web/Cardiac%20Safety%20Monitoring%20V2_Factsheet_Thumbnail.jpg?h=240&itok=09tQv_CL" width="170" height="240" alt="Cardiac Safety Monitoring V2_Factsheet_Thumbnail.jpg" loading="lazy" title="Cardiac Safety Monitoring V2_Factsheet_Thumbnail.jpg" /> </div> </div> </div> </span> <span class="file__details"> <h3>Factsheet: Cardiac Safety Monitoring</h3> <p>Ensuring the highest levels of safety and accuracy in your trials</p> </span> </a> </div> </div> </div> </div> <div id="b7c8fb2a-1470-41de-91fa-8e91228316db"> <div> <div class="file file--with-thumbnail"> <div class="container-fluid container-fluid--xl"> <a href="https://www2.iconplc.com/Factsheet_Cardiac_Monitoring_Devices" target="_blank" title="Factsheet: Cardiac Monitoring Device Portfolio for clinical trials"> <span class="file__thumbnail"> <div> <div><div><img src="https://icon.widen.net/content/aef19c40-90b4-43d7-b0b2-0514e0a25801/web/Cardiac%20Monitoring%20Devices%20V2_Factsheet_Thumbnail.jpg?h=240&itok=Mib0AzCa" width="170" height="240" alt="Cardiac Monitoring Devices V2_Factsheet_Thumbnail.jpg" loading="lazy" title="Cardiac Monitoring Devices V2_Factsheet_Thumbnail.jpg" /> </div> </div> </div> </span> <span class="file__details"> <h3>Factsheet: Cardiac Monitoring Device Portfolio for clinical trials</h3> </span> </a> </div> </div> </div> </div> <div id="3d221388-9c9b-41d4-9122-cfb5e81383b1"> <div class="bg-light"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Find out more:</h2> <h3> </h3> <div><p>Discover how ICON can enhance your clinical trials with high quality cardiac safety data and analysis that will ensure both the safety of your patients and the success of your clinical trial submission.</p></div> <a class="btn btn-primary btn-md" href="/contact" target="_self">Contact us</a> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="layout layout--onecol"> <div class="layout__region layout__region--content"> <div id="6dd73cb6-6739-4580-abe1-4f72009a3581"> <div class="group group--with-carousel bg-white content-visibility--auto contain-intrinsic-size--400 related-content-carousel"> <div class="container-fluid container-fluid--xl"> <h2 class="group__title"> Related information: </h2> <div class="carousel--standard carousel--standard-1-3-4"> <a class="carousel__item block-link" href="https://icon.widen.net/s/rrnj67lwsn" target="_blank"> <div class="card card--with-solid-bg card--with-solid-bg-purple" data-mh="related-content"> <div class="card-body"> <i aria-hidden="true" class="icon icon-download"></i> <span class="badge badge--with-arrow">Case Study</span> <h4 class="card-title m-0"> Analysing and reporting limited data to demonstrate cardiovascular safety in a rare disease study </h4> </div> </div> </a> <a class="carousel__item block-link" href="https://www2.iconplc.com/Case_Study_Cardiac_PAH" target="_blank"> <div class="card 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