Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 8:25 AM
Study NCT ID:
NCT01379261
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHILL-MI
Brief Summary:
The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.
Detailed Description:
Acute myocardial infarction (AMI) is the leading cause of mortality in the western world today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial salvage, it has been described that the reperfusion in itself may cause additional damage to the myocardium (reperfusion injury). In the safety \& feasibility trial RAPID MI-ICE we demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk. The aim of the present study is to confirm this finding in a larger multicenter trial.
The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.
The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: