Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months.

Conditions

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ST-elevation MI Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic Hypothermia Treatment

Group Type EXPERIMENTAL

Velomedix APLS device

Intervention Type DEVICE

Velomedix, Automated Peritoneal Lavage System

No Hypothermia Treatment

control group is no hypothermia treatment

Group Type ACTIVE_COMPARATOR

No Hypothermia Treatment

Intervention Type OTHER

Interventions

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Velomedix APLS device

Velomedix, Automated Peritoneal Lavage System

Intervention Type DEVICE

No Hypothermia Treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical symptoms consistent with acute STEMI lasting at least 30 minutes
* STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads
* Patient eligible for PCI

Exclusion Criteria

* Cardiac arrest with return of spontaneous circulation
* Known prior history of MI
* Known history of severe COPD requiring supplemental home oxygen
* Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device
* Known severe anemia or abnormal platelet count
* Known significant renal insufficiency
* Known contraindication for MRI
* Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No