Clinical Trial: Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Acut

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Philips Healthcare

Current Primary Outcome: Cardiac MRI infarct size as a percentage of left ventricle size in the per protocol population. [ Time Frame: Day 4 ]

Original Primary Outcome: Cardiac MRI infarct size as a percentage of left ventricle size at four days in the per protocol population.

Current Secondary Outcome:

  • MRI 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 [ Time Frame: Day 30 ]
  • 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 as a function of time [ Time Frame: Day 1 ]


Original Secondary Outcome:

  • MRI infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population
  • Myocardial necrosis: CK-MB release through 24 hours as area under the curve
  • NYHA/AHA Cardiac Functional Class at Day 30
  • MACE: Death, MI, re-hospitalization during the first year
  • Angiographic outcomes (TIMI flow grade, TIMI myocardial perfusion grade)
  • ST-segment resolution as a function of time


Information By: Philips Healthcare

Dates:
Date Received: January 2, 2007
Date Started: January 2007
Date Completion:
Last Updated: January 14, 2010
Last Verified: January 2010