Philips announces completion of patient enrolment in therapeutic hypothermia study

10 May 2013

Patient enrollment has been completed for the CHILL-MI clinical study designed to further evaluate the Philips' InnerCool RTx endovascular cooling system in patients with ST-elevation myocardial infarction (STEMI).

The primary objective of the study is reduction of myocardial infarct size as a percentage of myocardium at-risk, assessed by cardiac magnetic resonance imaging (MRI) at 4 days (± 2 days). Secondary safety and efficacy endpoints are also being evaluated.

Acute myocardial infarction (AMI) is one of the leading causes of mortality, with STEMI being the most severe form of AMI. In the US and Europe, the incidence of STEMI is 770-800 per million respectively. In hospital, mortality for STEMI patients ranges between 4.2-13.5 percent. Initiating percutaneous coronary intervention or primary PCI as early as possible is critical to the survival of heart tissue.

Research has shown that following an acute myocardial infarction, restoring blood flow to the heart is critical to the survival of heart tissue. However, this process may cause additional damage known as reperfusion injury. Preventing heart tissue damage is a significant unmet medical need in the treatment of acute myocardial infarction. Endovascular cooling is a method for quickly achieving therapeutic hypothermia — reducing a patient’s body temperature to help lower the amount of tissue injury.

Previous research has shown that therapeutic hypothermia can reduce infarct size in patients whose body temperature reaches ≤35°C prior to reperfusion or opening of the blocked artery. The previously published Rapid MI-ICE study, which utilized the InnerCool system, showed a 38 percent reduction in infarct size in STEMI patients who were cooled to a body temperature of ≤35°C before primary PCI.

The Philips InnerCool RTx endovascular system cools patients from the inside out. A unique heat-exchange catheter with an integrated temperature sensor is positioned below the heart via the femoral vein and connected to a proprietary console. The closed-loop system rapidly cools the patient and monitors core body temperature without fluid introduction or exchange by circulating cool saline in the catheter.

The Philips InnerCool RTx endovascular cooling system is commercially available in the United States, but is limited by applicable law to investigational use for the treatment of myocardial infarction.

Further information

See also the MTB Europe article: Inner cooling reduces heart and brain damage after MI, cardiac arrest and stroke


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