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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01643551
Other study ID # 1204M12861
Secondary ID
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


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
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