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Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

NCT01655433 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-07-25

No results posted yet for this study

Summary

This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.

Conditions

  • ST-elevation MI
  • Hypothermia

Interventions

DEVICE

Velomedix APLS device

Velomedix, Automated Peritoneal Lavage System

OTHER

No Hypothermia Treatment

Sponsors & Collaborators

  • Velomedix, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregg Stone, MD · New York Presbyterian Hospital / Columbia University Medical Center

  • Graham Nichol, MD · University of Washington, Harberview Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada

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 NCT01655433 on ClinicalTrials.gov