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CompletedNCT01643551NSE-LVADUpdated Dec 18, 2014

Neuron Specific Enolase in Ventricular Assist Device Recipients

An observational study in Advanced Heart Failure and Left Ventrucular Assist Device, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-18.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
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Study summary

An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Read the detailed description

Patients eligible for left ventricular assist device (LVAD) typically have severe heart failure, which is characterized by poor cardiac output. The relatively abrupt increase in cardiac output that follows implant of a LVAD may cause reperfusion injury. Furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. Neuron specific enolase (NSE) has been established as a biomarker of reperfusion injury. We hypothesize that changes in NSE following LVAD will be greater than the changes in NSE noted in a control population of patients undergoing non-VAD cardiac surgery.

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Conditions studied

  • Advanced Heart Failure
  • Left Ventrucular Assist Device

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Keywords

  • Heart Failure
  • Left Ventricular Assist Device
  • Reperfusion Injury
  • Neuron Specific Enolase
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 15 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.

Inclusion criteria

Group 1 - Pre-VAD implantation patients

  • 18 years and older
  • lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group
  • 18 years or older
  • Planning to undergo valve or coronary bypass surgery

Exclusion criteria

Exclusion Criteria:

  • Acute cerebrovascular infarction
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
15 participants (actual)

Groups and cohorts

  • LVAD Group

    18 years and older Planning to undergo VAD implantation

  • Cardiac Surgery Group

    18 years or older Planning to undergo valve or coronary bypass surgery

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What researchers measure

Primary outcomes

  1. Neuron-Specific Enolase

    Time frame: Pre and post-surgery

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Study locations

1 site
  • University of Minnesota Medical Center-Fairview
    Minneapolis, Minnesota 55455, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01643551
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
Jun 2012
Primary completion
Jan 2013
Completion
Jul 2013
Last update
Dec 18, 2014

Study contacts

Peter M Eckman, MD
principal investigator · University of Minnesota
Demitri Yannopoulos, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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