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Neuron Specific Enolase in Ventricular Assist Device Recipients

NCT ID: NCT01643551

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Heart Failure Left Ventrucular Assist Device

Keywords

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Heart Failure Left Ventricular Assist Device Reperfusion Injury Neuron Specific Enolase

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LVAD Group

18 years and older Planning to undergo VAD implantation

No interventions assigned to this group

Cardiac Surgery Group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter M Eckman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Demitri Yannopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1204M12861

Identifier Type: -

Identifier Source: org_study_id