Neuron Specific Enolase in Ventricular Assist Device Recipients (NSE-LVAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01643551
First received: July 16, 2012
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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


Condition
Advanced Heart Failure
Left Ventrucular Assist Device

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuron Specific Enolase in Ventricular Assist Device Recipients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Neuron-Specific Enolase [ Time Frame: Pre and post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643551

Locations
United States, Minnesota
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter M Eckman, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Demitri Yannopoulos, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01643551     History of Changes
Other Study ID Numbers: 1204M12861
Study First Received: July 16, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Heart Failure
Left Ventricular Assist Device
Reperfusion Injury
Neuron Specific Enolase

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014