Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT00417638
Study type Interventional
Source ZOLL Circulation, Inc., USA
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date October 2009

See also
  Status Clinical Trial Phase
Completed NCT00976521 - The INFUSE - Anterior Myocardial Infarction (AMI) Study N/A
Completed NCT04871126 - Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction
Recruiting NCT01936103 - Effects of Intensive Statin Treatment on Left Ventricular Function Phase 4