NCT01643551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

July 16, 2012

Last Update Submit

December 16, 2014

Conditions

Advanced Heart FailureLeft Ventrucular Assist Device

Keywords

Heart FailureLeft Ventricular Assist DeviceReperfusion InjuryNeuron Specific Enolase

Outcome Measures

Primary Outcomes (1)

  • Neuron-Specific Enolase

    Pre and post-surgery

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.

You may qualify if:

  • Group 1 - Pre-VAD implantation patients
  • years and older
  • lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group
  • years or older
  • Planning to undergo valve or coronary bypass surgery

You may not qualify if:

  • Acute cerebrovascular infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart FailureReperfusion Injury

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter M Eckman, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Demitri Yannopoulos, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(1)