TY - JOUR
T1 - Rationale and design of the AngeLmed for early recognition and treatment of STEMI trial
T2 - A randomized, prospective clinical investigation
AU - Gibson, Michael C.
AU - Krucoff, Mitchell
AU - Fischell, David
AU - Fischell, Tim A.
AU - Keenan, David
AU - Abueg, Cassandra
AU - Patel, Charmaine
AU - Holmes, David
N1 - Funding Information:
The trial is funded by Angel Medical Systems. The authors are responsible for the design and conduct of the trial, all trial analyses, drafting and editing the paper, and its final contents. The trial conduct is overseen by an executive committee that consists of members of the academic leadership of the trial and members from the sponsoring company. The executive committee provides oversight of trial conduct and data analysis, oversees publication of the trial results, and receives recommendations from the data safety monitoring board regarding possible additional analysis of modifications to the trial. The independent Clinical Events Adjudication Committee (CEAC) is composed of physicians who are external to both the sponsor and the trial and who possess the appropriate expertise to adjudicate events and to identify the relationship between trial events and the study device.
PY - 2014/8
Y1 - 2014/8
N2 - Significant improvements in door-to-balloon times have led to a reduction in mortality in ST-segment elevation myocardial infarction; however, mean symptom-to-door times remain at 2 to 3 hours. An intracardiac electrogram monitoring device may be beneficial in high-risk patients by alerting them to rapidly progressive ST-segment changes indicative of acute coronary occlusion. The Cardiosaver and DETECT phase I clinical studies demonstrated the safety, feasibility, and potential benefit of using an intracardiac electrogram monitoring device to alert the patient to seek medical attention. The goal of the randomized, prospective ALERTS Trial (Clinicaltrials.gov no. NCT00781118) is to evaluate the efficacy of an implantable monitoring device (IMD) in reducing the composite of either cardiac or unexplained death, new Q-wave myocardial infarction, or symptom-to-door time of >2 hours for confirmed thrombotic events. The IMD alerts the patient in real time when ST-segment deviation from a personalized baseline exceeds the trigger threshold. The trial is designed to enroll high-risk post-acute coronary syndrome patients or patients with previous multivessel coronary artery bypass surgery. All patients have the IMD implanted, with 1:1 unblinded randomization to the alerting feature being either turned on versus turned off for the first 6 months. Randomization occurs at the first follow-up visit, 7 to 14 days after the implantation of the IMD. Subjects then return for follow-up visits at months 1, 3, and 6 and thereafter every 6 months until closure of the investigational device exemption. Subjects who cannot be implanted successfully or who have the device explanted are removed from the study and followed up for a minimum of 30 days post-procedure. If a subject experiences a device-related complication and/or adverse experience, the subject is followed up until resolution or until the condition becomes stable and no further change is anticipated.
AB - Significant improvements in door-to-balloon times have led to a reduction in mortality in ST-segment elevation myocardial infarction; however, mean symptom-to-door times remain at 2 to 3 hours. An intracardiac electrogram monitoring device may be beneficial in high-risk patients by alerting them to rapidly progressive ST-segment changes indicative of acute coronary occlusion. The Cardiosaver and DETECT phase I clinical studies demonstrated the safety, feasibility, and potential benefit of using an intracardiac electrogram monitoring device to alert the patient to seek medical attention. The goal of the randomized, prospective ALERTS Trial (Clinicaltrials.gov no. NCT00781118) is to evaluate the efficacy of an implantable monitoring device (IMD) in reducing the composite of either cardiac or unexplained death, new Q-wave myocardial infarction, or symptom-to-door time of >2 hours for confirmed thrombotic events. The IMD alerts the patient in real time when ST-segment deviation from a personalized baseline exceeds the trigger threshold. The trial is designed to enroll high-risk post-acute coronary syndrome patients or patients with previous multivessel coronary artery bypass surgery. All patients have the IMD implanted, with 1:1 unblinded randomization to the alerting feature being either turned on versus turned off for the first 6 months. Randomization occurs at the first follow-up visit, 7 to 14 days after the implantation of the IMD. Subjects then return for follow-up visits at months 1, 3, and 6 and thereafter every 6 months until closure of the investigational device exemption. Subjects who cannot be implanted successfully or who have the device explanted are removed from the study and followed up for a minimum of 30 days post-procedure. If a subject experiences a device-related complication and/or adverse experience, the subject is followed up until resolution or until the condition becomes stable and no further change is anticipated.
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UR - http://www.scopus.com/inward/citedby.url?scp=84905118862&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2014.05.008
DO - 10.1016/j.ahj.2014.05.008
M3 - Article
C2 - 25066555
AN - SCOPUS:84905118862
SN - 0002-8703
VL - 168
SP - 168
EP - 174
JO - American heart journal
JF - American heart journal
IS - 2
ER -