NCT01655433

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

July 30, 2012

Last Update Submit

July 24, 2014

Conditions

ST-elevation MIHypothermia

Keywords

ST-elevation MIHypothermia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • MACE rate

    30 days

  • All cause mortality

    6 months

  • Myocardial infarct size

    3 days

Study Arms (2)

Therapeutic Hypothermia Treatment

EXPERIMENTAL
Device: Velomedix APLS device

No Hypothermia Treatment

ACTIVE COMPARATOR

control group is no hypothermia treatment

Other: No Hypothermia Treatment

Interventions

Velomedix APLS deviceDEVICE

Velomedix, Automated Peritoneal Lavage System

Therapeutic Hypothermia Treatment
No Hypothermia TreatmentOTHER
No Hypothermia Treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

LA County USC Hospital

Los Angeles, California, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

Victoria Heart Institute Foundation

Victoria, British Columbia, VSR 4R2,, Canada

Location

Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25699687DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gregg Stone, MD

    New York Presbyterian Hospital / Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

  • Graham Nichol, MD

    University of Washington, Harberview Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 25, 2014

Record last verified: 2014-07

Locations

CA(2)US(5)