Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction

NCT01379261 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-11-06

No results posted yet for this study

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.

Conditions

  • Myocardial Infarction
  • Myocardial Reperfusion Injury
  • Anterior Wall Myocardial Infarction
  • Inferior Wall Myocardial Infarction

Interventions

PROCEDURE

Cooling

1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY
  • Lund University

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Region Skane

    lead OTHER

Principal Investigators

  • David Erlinge, MD PhD · Department of Cardiology, Skane University Hospital, Lund, Sweden

  • Göran K Olivecrona, MD PhD · Department of Cardiology, Skane University Hospital, Lund, Sweden

  • Anthony Mullins · Philips Healthcare, San Diego, CA, USA

  • Lars Wallentin, MD PhD · Uppsala University Hospital, Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-09-30
Completion
2013-11-30

Countries

  • Austria
  • Denmark
  • Slovenia
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379261 on ClinicalTrials.gov