Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™ 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Department of Cardiology, Lund University Hospital
Lund, Sweden
Cardiac MRI infarct size
reduction in infarct size as a percentage of left ventricle size in the per protocol population.
Time frame: Day 4
MRI infarct size
Infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population
Time frame: Day 4
Myocardial necrosis
CK-MB release through 24 hours as area under the curve
Time frame: 24 Hours
NYHA/AHA Cardiac Functional Class
used to describe stages of Heart Failure ( Class I, II, III and IV)
Time frame: Day 30
Major Adverse Cardiac Events (MACE)
MACE: Death, MI, re-hospitalization
Time frame: Month 12
Angiographic outcomes
TIMI flow grade, TIMI myocardial perfusion grade
Time frame: Day 1
ST-segment resolution
ST-segment resolution as a function of time
Time frame: Day 1
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