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Completed

NCT Number: NCT01643551

Neuron Specific Enolase in Ventricular Assist Device Recipients

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

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Key information

Conditions

Advanced Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Left Ventrucular Assist Device Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neuron-Specific Enolase

    Time frame: Pre and post-surgery

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: NSE-LVAD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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