The East Texas Medical Center Cardiovascular Institute has enrolled its first patient in a new trial sponsored by St. Jude Medical that will contribute to the study of a device that could help detect acute coronary syndrome events, such as a heart attack.
"We are proud to participate in this trial in conjunction with Cardiovascular Associates of East Texas," commented John Stewart, vice president of ETMC. "We recognize the potential this new feature has to help save lives and enhance the care we can provide to patients. We look forward to contributing to the study."
ETMC is one of 200 nationwide centers participating in the ST Monitoring to Detect ACS (Acute Coronary Syndrome) Events in ICD Patients study, known as the Analyze ST trial. The trial will study the safety and effectiveness of a new feature in the device maker's Fortify® ST implantable cardioverter defibrillator (ICD) system. Dr. Noah Israel with CAET performed the procedure at ETMC.
More than half of patients experiencing a heart attack die before reaching a hospital. Even patients with stable coronary artery disease (CAD) are at high risk of having a life-threatening or potentially fatal coronary event. Additionally, 15 to 20 percent of patients who have had an ischemic event have recurrent events. As a result, CAD needs to be managed on an ongoing basis to avoid a more unstable or life threatening acute coronary event.
Approximately two thirds of ICD patients have cardiac ischemia (narrowing or blockage responsible for significantly obstructing the flow of blood to a patient's heart muscle), with many more having risk factors for developing cardiovascular disease.
The ST monitoring feature in the Fortify ST ICD is designed to detect a coronary event, such as a heart attack, by monitoring changes in a specific section of the patient's heartbeat - the ST segment. Changes in the ST segment have long been studied via surface electrocardiograms. This unique feature adds a new diagnostic capability to the ICD system so that physicians can automatically monitor the ST segment from inside the body and on a continual basis.
The Analyze ST study will determine if this diagnostic capability can provide detection of acute coronary syndrome events, and may provide important insights leading up to an event. The study will also provide key insights on the value of such a diagnostic feature in possibly reducing the event-to-treatment time and positively impacting patient outcomes.
As part of this new feature, a transmitter will provide updates to physicians who will then be able to remotely monitor their patients' ST segment changes. The device can also alert the patient to a change in the ST segment, prompting them to seek medical attention.
Earlier this year, St. Jude Medical received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start its Analyze ST trial. The technology has been an available feature in St. Jude Medical ICDs in Europe since 2008, but this is the first trial to study the device's use in the U.S. In all, more than 5,000 patients will participate in the study to evaluate the effectiveness and safety of the new ST monitoring feature.
For more information on the Analyze ST trial, visit www.sjm.com