Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Hypothermia Clinical Trial

— VELOCITY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01655433
• Other study ID #: VMXP-2490
• Status: Terminated
• Phase: Phase 2
• First received: July 30, 2012
• Last updated: July 24, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Velomedix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hypothermia
• ST-elevation MI

Intervention

Device:
• Velomedix APLS device
Velomedix, Automated Peritoneal Lavage System

Other:
• No Hypothermia Treatment

Locations

Country	Name	City	State
Canada	Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)	Quebec City	Quebec
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	LA County USC Hospital	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Velomedix, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	Yes
Secondary	MACE rate	MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days	30 days	Yes
Secondary	All cause mortality	All cause mortality through 6 months	6 months	Yes
Secondary	Myocardial infarct size	Myocardial infarct size at 3 days post-procedure	3 days	No