ST-elevation MIPhase 2VELOCITYNCT01655433
Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
A Phase 2 study testing Velomedix APLS device and No Hypothermia Treatment in people with ST-elevation MI and Hypothermia, run by Velomedix, Inc. at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST-elevation MI, Hypothermia
- What is being tested?
- Velomedix APLS device and No Hypothermia Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Heart Center Research, LLC
Huntsville, Alabama, 35801
LA County USC Hospital
Los Angeles, California
Vanderbilt University
Nashville, Tennessee
Ochsner Medical Center
New Orleans, Louisiana
Canada2 sites
Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)
Québec, Quebec, G1V 4G5
Victoria Heart Institute Foundation
Victoria, British Columbia, VSR 4R2,
About this study
Official title: VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
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.
Read the 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.
- Conditions
- ST-elevation MI, Hypothermia
- Being tested
- Velomedix APLS device, No Hypothermia Treatment
- Keywords
- ST-elevation MI, Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velomedix APLS deviceDevice
Velomedix, Automated Peritoneal Lavage System
No Hypothermia TreatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Hypothermia Treatment | Experimental | Not described Receives: Device: Velomedix APLS device |
| No Hypothermia Treatment | Active comparator | control group is no hypothermia treatment Receives: Other: No Hypothermia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
MACE rate
MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
Measured: 30 days
All cause mortality
All cause mortality through 6 months
Measured: 6 months
Myocardial infarct size
Myocardial infarct size at 3 days post-procedure
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Sponsor business decision, not safety related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-elevation MIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Velomedix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Stone, MD, Principal investigator, New York Presbyterian Hospital / Columbia University Medical CenterGraham Nichol, MD, Principal investigator, University of Washington, Harberview Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655433
- Sponsor's protocol ID
- VMXP-2490
- Acronym
- VELOCITY
- Status last verified
- Jul 2014
- First submitted
- 30 Jul 2012
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25699687
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01655433
- Acronym / sponsor ID
- VELOCITY / VMXP-2490
- Conditions
- ST-elevation MI, Hypothermia
- Keywords
- ST-elevation MI, Hypothermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision, not safety related
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Velomedix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Hypothermia Treatment | Experimental | Device: Velomedix APLS device |
| No Hypothermia Treatment | Active comparator | Other: No Hypothermia Treatmentcontrol group is no hypothermia treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velomedix APLS deviceVelomedix, Automated Peritoneal Lavage System | Device | Therapeutic Hypothermia Treatment |
| No Hypothermia Treatment | Other | No Hypothermia Treatment |
Primary outcome
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.
3 secondary outcomes
MACE rate
Time frame: 30 days
All cause mortality
Time frame: 6 months
Myocardial infarct size
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Sponsor business decision, not safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Derived from this study: PubMed 25699687Nichol 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.
Related trials for ST-elevation MI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg Stone, MD principal investigator
New York Presbyterian Hospital / Columbia University Medical Center
Graham Nichol, MD principal investigator
University of Washington, Harberview Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velomedix APLS device and No Hypothermia Treatment in people with ST-elevation MI and Hypothermia, run by Velomedix, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision, not safety related). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of new-onset SAEs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.