Trials / Completed
CompletedNCT01379261
Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
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
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Region Skane · Academic / Other
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myocardial Infarction
- Myocardial Reperfusion Injury
- Anterior Wall Myocardial Infarction
- Inferior Wall Myocardial Infarction
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cooling | 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2013-09-01
- Completion
- 2013-11-01
- First posted
- 2011-06-23
- Last updated
- 2014-11-06
Locations
10 sites across 4 countries: Austria, Denmark, Slovenia, Sweden
Source: ClinicalTrials.gov record NCT01379261. Inclusion in this directory is not an endorsement.