Study |
Trial design |
Patient population |
n = |
Cooling method |
Target temp |
Cooling time |
Primary Endpoint |
Secondary Endpoint |
Reperfusion therapy |
Results |
Dixon et al., 2002 11 |
Prospective RCT |
STEMI within 6 hrs of onset |
42 |
Endovascular catheter |
33°C |
4 hours |
MACE at 30 days |
Infarct size at 30 days * |
Primary PCI |
Non-significant decrease in MACE and infarct size |
COOL MI
O'Neill et al., 2003 12 |
Prospective RCT |
STEMI within 6 hrs of onset |
357 |
Endovascular catheter |
33°C |
n/a |
Infarct size and MACE at 30 days * |
ST segment resolution, LVEF,
CK-MB and myoglobin release |
Primary PCI |
No difference in MACE or infarct size
Non-significant reduction in infarct size with anterior MI ‡ |
COOL MI II
Carrozza et al., 2005 45 |
Prospective RCT |
Anterior STEMI within 6 hrs of onset |
n/a |
Endovascular catheter |
33°C |
n/a |
Infarct size *
Safety profile |
Infarct size,
ST segment resolution, LVEF † |
Primary PCI |
Trial halted prior to completion due to funding reasons |
LOWTEMP
Kandzari et al., 2004 41 |
Feasibility cohort |
STEMI within 6 hrs of onset |
20 |
Endovascular catheter |
32-34°C |
4 hours |
Infarct size at 30 days *,† |
ST-segment resolution |
Primary PCI |
Feasible, associated with favorable safety, infarct size and ST-segment resolution outcomes |
ICE-IT
Grines et al., 2004 13 |
Prospective RCT |
Anterior or large inferior STEMI within 6 hrs of onset |
228 |
Endovascular catheter |
32-34°C |
6 hours |
Infarct size at 30 days * |
n/a |
Primary PCI |
No difference in infarct size
Non-significant reduction in infarct size with anterior MI ‡ |
Hovdenes et al., 2007 53 |
Prospective observational |
Comatose, VF- OHCA eligible for PCI |
50 |
Cold NS infusion and external cooling |
32-34°C |
24 hours |
Survival and neurological outcome at 6 months # |
n/a |
Primary or facilitated PCI |
82% survival at 6 months
Larger infarct size in those with unfavorable neurological outcome †,‡ |
Wolfrum et al., 2008 48 |
Prospective observational with historical controls |
Comatose, VF-OHCA with STEMI |
33 |
Cold NS infusion and external cooling |
32-34°C |
24 hours |
Survival and neurological outcome at 6 months # |
n/a |
Primary PCI |
10% mortality reduction, improved neurological outcome
Non-significant reduction in infarct size with anterior MI ‡ |
Schefold et al., 2009 54 |
Prospective observational with historical controls |
Comatose, OHCA with STEMI |
62 |
Cold NS infusion and external cooling |
33°C |
24 hours |
Survival and neurological outcome at discharge # |
Bleeding complications
** |
Thrombolysis, PCI |
Improved neurological outcome
Non-significant reduction in infarct size |
Gotberg et al., 2010 45 |
Prospective RCT |
STEMI within 6 hrs of onset |
20 |
Cold NS infusion and endovascular catheter |
33°C |
3 hours |
Myocardium at risk and infarct size after 4 days *** |
n/a |
Primary PCI |
38% reduction in infarct size normalized to myocardium at risk |
