Study name | Dixon et al6 | COOL-MI7 | ICE-IT8 | RAPID MI-ICE9 | CHILL-MI 10 | VELOCITY11 |
---|---|---|---|---|---|---|
Total number of patients | 42 | 392 | 228 | 20 | 120 | 54 |
Age (years), (control vs TH) | 58 vs 52 | 59 vs 60 | 57 vs 57 | 58 vs 62 | 59 vs 57 | 57 vs 57 |
Male (%), (control vs TH) | 76 vs 90 | 74 vs 76 | 80 vs 75 | 78 vs 78 | 86 vs 79 | 81 vs 89 |
DM status (%), (control vs TH) | 29 vs 19 | 18 vs 17 | N/A | 22 vs 11 | 5 vs 13 | 23 vs 21 |
HTN (%), (control vs TH) | 57 vs 24 | 39 vs 47 | N/A | 22 vs 33 | 12 vs 28 | 34 vs 50 |
HLD (%), (control vs TH) | 24 vs 43 | 30 vs 31 | N/A | N/A | 2 vs 16 | 23 vs 36 |
Current smoker (%), (control vs TH) | 52 vs 67 | 48 vs 44 | N/A | N/A | 39 vs 46 | 44 vs 43 |
Prior MI (%), (control vs TH) | 5 vs 14 | 12 vs 10 | N/A | N/A | N/A | 0 vs 0 |
Follow-up time (days) | 30 | 30 | 360 | 4±2 days | 6-month | 180 (30 for imaging follow-up) |
Primary end point | MACE at 30 days | IS* and MACE at 30 days | IS* at 30 days | Safety profile including 30-day mortality, reinfarction, heart failure | IS by CMR in 4±2 days, mortality and heart failure at 45 days | IS by CMR at 3–5 days, composite safety profile |
Secondary end point | IS* at 30 days | ST segment resolution, LVEF by SPECT, CK-MB release | CK-MB release, NYHA FC at 30 days, MACE | IS by CMR in 4±2 days, troponin and CK-MB release | Safety profile | CMR MVO, LV volumes, EF at 3–5 days and 30 days, MACE, TIMI bleeding, ST segment resolution |
Specific end points comprising MACE | Death, non-fatal reinfarction, TVR | Death, reinfarction, TVR | Death, reinfarction, stroke, heart failure, cardiogenic shock | N/A | N/A | Cardiac death, reinfarction, TVR |
*Measured by 99m Tc-sestamibi SPECT imaging.
CHILL-MI, Efficacy of Endovascular Catheter Cooling Combined with Cold Saline for the Treatment of Acute Myocardial Infarction; CK-MB, creatine kinase-MB isoform; CMR, cardiac MRI; COOL-MI, Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction; DM, diabetes mellitus; EF, ejection fraction; HTN, hypertension; ICE-IT, Intravascular Cooling Adjunctive to Percutaneous Coronary Intervention; IS, infarct size; LV, left ventricle; MACE, major adverse cardiac event MI, myocardial infarction; MVO, microvascular obstruction; N/A, not available; NYHA FC, New York Heart Association Functional Class; RAPID MI-ICE, Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention study; SPECT, single photon emission CT; TH, therapeutic hypothermia; TIMI, thrombolysis in myocardial infarction; TVR, target vessel revascularisation; VELOCITY, Prospective, Multicenter, Randomised, Controlled Pilot Trial of Peritoneal Hypothermia in Patients With ST Segment Elevation Myocardial Infarction.