Neuron Specific Enolase in Ventricular Assist Device Recipients

Advanced Heart Failure Clinical Trial

— NSE-LVAD  

Official title:

Neuron Specific Enolase in Ventricular Assist Device Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643551
• Other study ID #: 1204M12861
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: December 16, 2014
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• Acute cerebrovascular infarction

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure
• Left Ventrucular Assist Device

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center-Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuron-Specific Enolase		Pre and post-surgery	No