EUROpean Intracoronary Cooling Evaluation in Patients With ST-elevation Myocardial Infarction.

NAUnknownINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

September 30, 2022

Study Completion Date

June 30, 2023

Conditions
Acute Myocardial InfarctionReperfusion Injury
Interventions
OTHER

Selective intracoronary hypothermia + PPCI

Selective intracoronary hypothermia is a new technique, recently tested for safety and feasibility in the SINTAMI trial. The procedure starts by advancing a guidewire beyond the occlusion in the culprit artery, followed by an OTWB that is inflated at the location of the occlusion, at a low pressure (4 atm), to prevent reperfusion. After that, a pressure/temperature wire will be advanced along the inflated OTWB and is placed in the distal coronary artery. Then the guidewire is removed and the lumen is used for infusion of saline. During the 'occlusion phase', saline at room temperature is infused for 10 minutes with distal coronary temperature 6-8°C below body temperature. After that, the balloon of the OTWB is deflated. Simultaneously, infusion is started with saline of 4°C, the so called 'reperfusion phase'. This is continued for 10 more minutes. After that, the OTWB can be retracted and the procedure can continue not different from routine PPCI.

OTHER

Standard PPCI

PPCI per routine

Trial Locations (1)

5623 EJ

Catharina hospital, Eindhoven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

collaborator

Golden Jubilee National Hospital

OTHER_GOV

collaborator

Onze Lieve Vrouwziekenhuis Aalst

OTHER

collaborator

Rigshospitalet, Denmark

OTHER

collaborator

Örebro University, Sweden

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

University of Belgrade

OTHER

collaborator

Mid and South Essex NHS Foundation Trust

OTHER

lead

Catharina Ziekenhuis Eindhoven

OTHER

NCT03447834 - EUROpean Intracoronary Cooling Evaluation in Patients With ST-elevation Myocardial Infarction. | Biotech Hunter | Biotech Hunter