Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (VELOCITY)

This study is not yet open for participant recruitment.

Verified July 2012 by Velomedix, Inc.

Sponsor:

Information provided by (Responsible Party):

Velomedix, Inc.

ClinicalTrials.gov Identifier:

NCT01655433

First received: July 30, 2012

Last updated: NA

Last verified: July 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 30, 2012

Last Updated Date

July 30, 2012

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite of new-onset SAEs [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

MACE rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
All cause mortality through 6 months
Myocardial infarct size [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Myocardial infarct size at 3 days post-procedure

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Official Title ^ICMJE

VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

ST-elevation MI
Hypothermia

Intervention ^ICMJE

Device: Velomedix APLS device
Velomedix, Automated Peritoneal Lavage System
Other: No Hypothermia Treatment

Study Arm (s)

Experimental: Therapeutic Hypothermia Treatment
Intervention: Device: Velomedix APLS device
Active Comparator: No Hypothermia Treatment
control group is no hypothermia treatment

Intervention: Other: No Hypothermia Treatment

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical symptoms consistent with acute STEMI lasting at least 30 minutes
Anterior MI with ST-elevation of >1mm
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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Griffeth Tully, MD

Chief Medical Officer

gtully@velomedix.com

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT01655433

Other Study ID Numbers ^ICMJE

VMXP-2490

Has Data Monitoring Committee

Yes

Responsible Party

Velomedix, Inc.

Study Sponsor ^ICMJE

Velomedix, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Gregg Stone, MD	New York Presbyterian Hospital / Columbia University Medical Center
Principal Investigator:	Graham Nichol, MD	University of Washington, Harberview Center

Information Provided By

Velomedix, Inc.

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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