Advanced Heart FailureNSE-LVADNCT01643551
Neuron Specific Enolase in Ventricular Assist Device Recipients
An observational study of Advanced Heart Failure and Left Ventrucular Assist Device, run by University of Minnesota at 1 site in United States.
Trial summary
An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure, Left Ventrucular Assist Device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.
Who may be able to join
- 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
Who cannot join
- Acute cerebrovascular infarction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455
About this study
An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.
Read the 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.
- Keywords
- Heart Failure, Left Ventricular Assist Device, Reperfusion Injury, Neuron Specific Enolase
- Medical subject headings
- Heart Failure, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Neuron-Specific Enolase
Measured: Pre and post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter M Eckman, MD, Principal investigator, University of MinnesotaDemitri Yannopoulos, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643551
- Sponsor's protocol ID
- 1204M12861
- Acronym
- NSE-LVAD
- Status last verified
- Dec 2014
- First submitted
- 16 Jul 2012
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuron Specific Enolase in Ventricular Assist Device Recipients
- ClinicalTrials.gov ID
- NCT01643551
- Acronym / sponsor ID
- NSE-LVAD / 1204M12861
- Keywords
- Heart Failure, Left Ventricular Assist Device, Reperfusion Injury, Neuron Specific Enolase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Acute cerebrovascular infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuron-Specific Enolase
Time frame: Pre and post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
Related trials for Advanced Heart Failure
Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Heart Failure, Heart Failure New York Heart Association Class III
Recruiting
Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
Advanced Heart Failure, Advanced Non-Colorectal Gastointestinal Cancer
Not yet recruiting
TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
Advanced Heart Failure, Acquired Heart Disease
Not yet recruiting
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
Advanced Heart Failure, Heart Transplantation
Not yet recruiting
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
Congenital Heart Disease, Advanced Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Eckman, MD principal investigator
University of Minnesota
Demitri Yannopoulos, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Heart Failure and Left Ventrucular Assist Device, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuron-Specific Enolase (time frame: Pre and post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.