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Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (VELOCITY)
This study has been terminated.
(Sponsor business decision, not safety related)
Sponsor:
Velomedix, Inc.
Information provided by (Responsible Party):
Velomedix, Inc.
ClinicalTrials.gov Identifier:
NCT01655433
First received: July 30, 2012
Last updated: July 24, 2014
Last verified: July 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| ST-elevation MI Hypothermia | Device: Velomedix APLS device Other: No Hypothermia Treatment | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Velomedix, Inc.:
Primary Outcome Measures:
- Composite of new-onset SAEs [ Time Frame: 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:
- MACE rate [ Time Frame: 30 days ]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 ]All cause mortality through 6 months
- Myocardial infarct size [ Time Frame: 3 days ]Myocardial infarct size at 3 days post-procedure
| Enrollment: | 54 |
| Study Start Date: | November 2012 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Therapeutic Hypothermia Treatment |
Device: Velomedix APLS device
Velomedix, Automated Peritoneal Lavage System
|
|
Active Comparator: No Hypothermia Treatment
control group is no hypothermia treatment
|
Other: No Hypothermia Treatment |
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655433
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655433
Locations
| United States, Alabama | |
| Heart Center Research, LLC | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| LA County USC Hospital | |
| Los Angeles, California, United States | |
| United States, Georgia | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Louisiana | |
| Ochsner Medical Center | |
| New Orleans, Louisiana, United States | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States | |
| Canada, British Columbia | |
| Victoria Heart Institute Foundation | |
| Victoria, British Columbia, Canada, VSR 4R2, | |
| Canada, Quebec | |
| Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval) | |
| Quebec City, Quebec, Canada, G1V 4G5 | |
Sponsors and Collaborators
Velomedix, Inc.
Investigators
| Principal Investigator: | Gregg Stone, MD | New York Presbyterian Hospital / Columbia University Medical Center |
| Principal Investigator: | Graham Nichol, MD | University of Washington, Harberview Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Velomedix, Inc. |
| ClinicalTrials.gov Identifier: | NCT01655433 History of Changes |
| Other Study ID Numbers: |
VMXP-2490 |
| Study First Received: | July 30, 2012 |
| Last Updated: | July 24, 2014 |
Keywords provided by Velomedix, Inc.:
|
ST-elevation MI Hypothermia |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on August 22, 2017