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

December 16, 2014 updated by: University of Minnesota
An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuron-Specific Enolase
Time Frame: Pre and post-surgery
Pre and post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Demitri Yannopoulos, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1204M12861

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe