Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Phase 2TerminatedNCT01655433

Velomedix, Inc.54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ST-elevation MI Hypothermia

Interventions

Velomedix APLS deviceDEVICE

Velomedix, Automated Peritoneal Lavage System

No Hypothermia TreatmentOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

Heart Center Research, LLC

Huntsville, Alabama, United States

LA County USC Hospital

Los Angeles, California, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

Composite of new-onset SAEs

Composite of new-onset serious adverse events, specifically death, ischemia driven target vessel revascularization (TVR), recurrent MI, pneumonia, sepsis, ventricular tachycardia or fibrillation requiring cardioversion, renal failure, peritonitis and significant bleeding.

Time frame: 30 days

Secondary Outcomes

MACE rate

MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days

Time frame: 30 days

All cause mortality

All cause mortality through 6 months

Time frame: 6 months

Myocardial infarct size

Myocardial infarct size at 3 days post-procedure

Time frame: 3 days

Data from ClinicalTrials.gov

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