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Previous clinical data suggested early and rapid cooling beforereperfusion therapy with primary angioplasty may potentially reduce infarctsize post reperfusion. The study will enroll up to twenty patients at twoinstitutions who present within six hours of symptom onset and require PCI torestore blood flow to the heart. Patients will receive hypothermia with theLife Recovery Systems ThermoSuit(R) non-invasive cooling system. Cooling willbe performed in the emergency room within 60 minutes of arrival and coolingtime is to be less than 30 minutes to avoid prolonging door-to-balloon timebeyond 90 minutes.
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The study is co-chaired by Dr. Paul McMullan and Dr. Christopher White,Chairman of Cardiology for Ochsner Health System in New Orleans, LA.
In the Cool MI I trial(1) a subset of patients with anterior infarctionsand whose temperature at the time of reperfusion was below 35 degrees C(26% of all anterior MI's in the cooled group) had a significantly smallerinfarction (9.3% of the left ventricular mass in the cooled population vs.18.2% in the control group p=0.05) than the control group, said Dr. PaulMcMullan.
The goal of this pilot study is to confirm the feasibility and efficacy ofexternal thin film liquid cooling to achieve "target" temperature within 30minutes or less, and to demonstrate ease of maintenance of target temperaturefor three hours following removal of the patient from ThermoSuit(R). Primarysafety endpoints data will also be collected. If this trial successfullyachieves it its endpoints, a larger prospective randomized trial will beconducted.
Life Recovery Systems is pleased to be working with world-renownedcardiologists from Ochsner Health System to study ThermoSuit(R) cooling in theAcute MI patient population. "We believe our rapid non-invasive coolingsystem has the ability to cool Acute MI patients to target temperature rapidlyin the emergency room in preparation for PCI reperfusion therapy," stated JohnDiLiddo, VP Marketing & Sales for Life Recovery Systems. A second U.S. siteis in the process of being chosen and will be announced in the near future.
Our goal is to rapidly cool the patient to target temperature in less than30 minutes in preparation for PCI and without exceeding the AHA/ACC guidelinesfor door-to-balloon time. A successful trial outcome could impact in apositive way thousands of patients each year worldwide who suffer severe AcuteMyocardial Infarctions.
Life Recovery Systems, HD, LLC is focused on developing and providinggroundbreaking, innovative medical devices for the emergency medical caremarket. The company's mission is to save and preserve the quality of lives.To learn more, visit us at www.life-recovery.com.
Ochsner Health System (www.ochsner.org) is a non-profit, academic, multi-specialty, healthcare delivery system dedicated to patient care, research andeducation. The system includes seven hospitals, a sub-acute facility, and 33health centers located throughout Southeast Louisiana. Ochsner employs over600 physicians in 80 medical specialties and subspecialties and 450 clinicalresearch trials annually. Ochsner was ranked one of the "Best Places to Work"by New Orleans City Business in 2005, 2006 and 2007 and received the ConsumerChoice for Healthcare in New Orleans for 12 consecutive years. Ochsner wasranked as "Best" Hospital by U.S. News and World Report in July 2007. Ochsnerhas over 10,000 employees system-wide.
1. O'Neill, W.W. A Prospective Randomized Trial of Mild Systemic
Hypothermia During PCI Treatment of ST Elevation MI (The
