Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Phase 2

Terminated

• Conditions: ST-elevation MI; Hypothermia
• Interventions: Other: No Hypothermia Treatment; Device: Velomedix APLS device

• Registration Number: NCT01655433
• Lead Sponsor: Velomedix, Inc.

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-08-01
• Study Start: 2012-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Hypothermia Treatment	No Hypothermia Treatment	control group is no hypothermia treatment
Therapeutic Hypothermia Treatment	Velomedix APLS device	-

Primary Outcome Measures

Name	Time	Method
Composite of new-onset SAEs	30 days	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.

Secondary Outcome Measures

Name	Time	Method
MACE rate	30 days	MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
All cause mortality	6 months	All cause mortality through 6 months
Myocardial infarct size	3 days	Myocardial infarct size at 3 days post-procedure

Trial Locations

Locations (7)

LA County USC Hospital; 🇺🇸 Los Angeles, California, United States

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval); 🇨🇦 Quebec City, Quebec, Canada

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Victoria Heart Institute Foundation; 🇨🇦 Victoria, British Columbia, Canada

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States