Acute Anterior Myocardial Infarction Clinical Trial
Official title:
A Randomized, Controlled Study of the Use of Central Venous Catheter Core Cooling Combined With Cold Saline, and Rewarming as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction
Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Controlâ„¢ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.
The CCS is an endovascular thermal control system that circulates cooled saline through an
indwelling central venous catheter in a closed-loop manner. The system has received 510(k)
approval from the FDA for use in temperature management in neuro-surgical and cardiac
patients during surgery and in recovery/intensive care. It has also received European CE mark
and Australian TGA approval. Animal data in a model of acute myocardial infraction support
the hypothesis that rapid cooling, prior to acute PCI, may reduce infarct size. Meta-analysis
of the previous acute MI trials ICE-IT (N = 228; 1:1 randomization, hypothermia : control,
Innercool Therapies, Inc.) and COOL MI-I (Radiant Medical, Inc) suggests there is a reduction
in infarct size as measured by 30-day SPECT in the population of patients with anterior MIs
who were cooled below 35 C prior to PCI.
This study is designed to investigate the safety, feasibility and efficacy of rapid
endovascular cooling in the setting of acute PCI in patients with anterior infarctions.
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Status | Clinical Trial | Phase | |
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Completed |
NCT00976521 -
The INFUSE - Anterior Myocardial Infarction (AMI) Study
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N/A | |
Completed |
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Phase 4 |