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COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

NCT02509832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-11-25

No results posted yet for this study

Summary

COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.

Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

Cooling + PCI

Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)

DEVICE

PCI only

Standard of Care for PCI

Sponsors & Collaborators

  • ZOLL Circulation, Inc., USA

    lead INDUSTRY

Principal Investigators

  • Michael Holzer · Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien

  • Marko Noc · University Medical Center Ljubljana Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-03-31
Completion
2018-06-30

Countries

  • Austria
  • Estonia
  • Hungary
  • Poland
  • Serbia
  • Slovenia
  • Sweden
  • United Kingdom

Study Locations

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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 NCT02509832 on ClinicalTrials.gov