Clinical trial NCT01655433: Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
Official title: VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: ST-elevation MI
Hypothermia
Keywords: ST-elevation MI
Hypothermia
Lead sponsor: Velomedix, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of new-onset SAEs
timeFrame: 30 days
Secondary outcomes:
measure: MACE rate
timeFrame: 30 days
measure: All cause mortality
timeFrame: 6 months
measure: Myocardial infarct size
timeFrame: 3 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Los Angeles
country: United States
facility: LA County USC Hospital
state: California
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Quebec City
country: Canada
facility: Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)
state: Quebec
Study officials:
affiliation: New York Presbyterian Hospital / Columbia University Medical Center
name: Gregg Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington, Harberview Center
name: Graham Nichol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nichol G, Strickland W, Shavelle D, Maehara A, Ben-Yehuda O, Genereux P, Dressler O, Parvataneni R, Nichols M, McPherson J, Barbeau G, Laddu A, Elrod JA, Tully GW, Ivanhoe R, Stone GW; VELOCITY Investigators. Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction. Circ Cardiovasc Interv. 2015 Mar;8(3):e001965. doi: 10.1161/CIRCINTERVENTIONS.114.001965. Epub 2015 Feb 19.