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Stroke, AcuteNCT03618290

Plasma Free Fatty Acids Profile As A Diagnostic Tool For Acute Ischemic Stroke

An observational study of Stroke, Acute, run by Sanford Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the research is to use plasma free fatty acid profiling as a biomarker for ischemic stroke. The plasma free acid profile will be specifically and significantly changed in early stages upon stroke onset, and correlate with the stroke volume and progression determined by imaging techniques. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute
What is being tested?
Analyze plasma free fatty acid in blood
How many people
102 participants
Where
1 siteUnited States
Study dates
19 Sep 2018to 7 Jan 2020
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: Patients admitted to the Sanford Health Fargo, ND Emergency Room for AIS, non-neurological pathologies such as CHF, COPD etc., or with traumatic or other non AIS-related brain injuries. These will include: intracranial hemorrhage or brain contusions.

Who may be able to join

  • Have onset of symptoms within 24-hours of presentation (AIS and Brain ?Trauma arms only).
  • 18-years old and older.
  • Able to offer informed consent after passing the MMSE with score ≥18 or able to obtain consent from legally authorized representative if MMSE score is ≤17.
  • Participants must be admitted to the hospital and stay for at least 24 hours.
  • Present with a traumatic or non AIS-related brain injury (non-AIS brain injury arm only).
  • Diagnosed with non-neurological pathology (non-neurological pathology arm only).

Who cannot join

  • Have onset of symptoms more than 24-hours before presentation (AIS and Brain Trauma arms).
  • Less than 18-years old.
  • Patients unwilling to provide consent with MMSE score of 18 or greater.
  • Legally authorized representative unable or unwilling to provide consent for patients with an MMSE score of 17 or less.
  • If they leave the hospital within 24 hours after being admitted.
  • No longer meeting the eligibility criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sanford Health

    Fargo, North Dakota, 58104

Other trials in United States

About this study

The purpose of the research is to use plasma free fatty acid profiling as a biomarker for ischemic stroke. The plasma free acid profile will be specifically and significantly changed in early stages upon stroke onset, and correlate with the stroke volume and progression determined by imaging techniques.

Read the detailed description

Ischemic stroke is the third leading cause of death and the leading cause of long-term disability in the United States. Immediate treatment can play a major role in the outcome of ischemic stroke and can help improve prognosis in many cases. One of the factors effecting immediate treatment is a rapid and accurate diagnostics of ischemic stroke.

Although imaging techniques remain to be the primary diagnostic instrumental tool, advanced imaging studies can slow management decisions and are sometimes unavailable. In addition, imaging studies often cannot discriminate between pre-existing lesions and acute or ongoing processes. Thus, additional diagnostic and prognosis tools such as plasma biomarkers will be beneficial for the early management of ischemic stroke. Importantly, the only FDA approved therapeutic treatment for ischemic stroke is tPA administration within 3-4.5 hours of stroke onset. Thus, the ideal biomarker for ischemic stroke would be readily detectible within this window for intravenous thrombolysis.

To date, the majority of potential stroke biomarkers studied are of peptide/protein nature and do not meet this requirement. One of the reasons is that hydrophilic substrates including peptides and proteins do not readily cross blood-brain barrier (BBB). Thus, brain specific peptides/proteins are unlikely to be significantly increased in plasma within the therapeutic windows of acute stroke conditions, but rather will be slowly increased during progression of stroke associated with BBB integrity loss. As a result, the most commonly utilized brain-specific protein biomarkers, including S100b and neuron specific enolase, do not increase in plasma before 10-18 hours, and do not correlate with infarct volume prior to 24 hours after injury. Many other brain-specific proteins studied have similar limitations, while proteins such as copeptin found elevated under acute stroke conditions are highly non-specific for the brain and may serve as a more general marker of physiologic stress. Another promising approach is utilization of blood gene expression analysis to identify the etiology of acute ischemic stroke. However, the timing of RNA expression measurement, as well as dynamics for RNA expression may add limitations to this approach to meet "the ideal ischemic stroke biomarker" requirement.

Alternatively, lipid biomarkers may overcome these limitations. Lipids are hydrophobic and readily cross the BBB, are very abounded accounting for about 10% of brain wet weight, have a brain specific profile, and alterations in brain lipids develop immediately upon ischemic injury. Recently, using a targeted quantification, a brain specific sphingolipid was identified as a promising biomarker for acute brain damage, demonstrating a feasibility of using lipid biomarkers to diagnose stroke.

In the current project, the investigators propose a novel approach of using plasma free fatty acid profiling as a biomarker for ischemic stroke. This novel approach is based on well documented features of brain lipid composition and metabolism under acute ischemia conditions. First, the brain has a unique signature of phospholipid fatty acid composition that is different from plasma and other tissues with one of the highest arachidonic, docosahexaenoic, and adrenic acid concentrations, that make up to 20% of fatty acids in the mammalian brain. These polyunsaturated fatty acids are mainly esterified in the sn-2 position on phospholipids and are released by a phospholipase of the A2 family. Secondly, lipids constitute more than half of the dry weight in human brain, making it the second greatest lipid containing organ in the body after adipose tissue, thus representing a significant potential source for fatty acids. Third, upon acute ischemic injury, brain phospholipases (predominantly A2 family) are immediately activated, leading to a rapid (within minutes) release of polyunsaturated fatty acids from sn-2 position from phospholipids in the free form. Because of the hydrophobicity of fatty acids, they are readily permeable for BBB and are expected to be found in plasma. Forth, dietary fatty acids are circulated in the esterified form, while released from adipose tissue free fatty acids have a different fatty acid profile, making brain free fatty acids distinguishable from other fatty acid pools in plasma.

The only FDA approved treatment for ischemic strokes is tissue plasminogen activator (tPA, also known as IV rtPA, given through an IV in the arm), administered within 3-4.5 hours of stroke onset. tPA works by dissolving the clot and improving blood flow to the part of the brain being deprived of blood flow. Although imaging techniques remain to be the primary diagnostic instrumental tool, advanced imaging studies can slow management decisions and are sometimes unavailable. In addition, imaging studies often cannot discriminate between pre-existing lesions and acute or ongoing processes. Thus, additional diagnostic and prognosis tools such as plasma biomarkers will be beneficial for the early management of ischemic stroke.

Conditions
Stroke, Acute
Being tested
Analyze plasma free fatty acid in blood
Keywords
Acute ischemic stroke, plasma free fatty acid
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analyze plasma free fatty acid in bloodDiagnostic test

    This study is prospectively designed with the purpose of investigating potential new lipid targets and the free fatty acids as specific markers of acute brain injury.

    Dynamic measurement of lipid profile in 3 consecutive samples at (I) the time intervals of admission, (II) 8 hours and (III) 24 hours after admission will give the opportunity of comparison mass-spectrometric analysis of highly complex plasma samples thus reducing variability between analyzed samples and allowing precise focusing on essential lipid target changes during stroke progression.

Study groups in NCT03618290
Study groupRoleWhat they receive
Acute ischemic stroke group50 patients (expected) - Acute ischemic stroke (AIS)
Receives: Diagnostic Test: Analyze plasma free fatty acid in blood
Non-neurological pathologies group25 control subjects with non-neurological pathologies (Congestive heart failure (CHF), Chronic obstructive pulmonary disease ( COPD ) etc.)
Receives: Diagnostic Test: Analyze plasma free fatty acid in blood
Non AIS-related brain injuries group25 control subjects with traumatic or other non AIS-related brain injuries. These will include: Traumatic Brain Injury (TBI) defined as intracranial hemorrhage or contusion.
Receives: Diagnostic Test: Analyze plasma free fatty acid in blood

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between lipid targets and an acute stroke incident

    Measured: Through study completion, anticipated through to July 11, 2019.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2018
  2. Study start19 Sep 2018
  3. Primary completion7 Jan 2020
  4. Study completion7 Jan 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618290
Sponsor's protocol ID
SHFASt2018
Status last verified
Jan 2020
First submitted
31 Jul 2018
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute, run by Sanford Health 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 6 inclusion and 6 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 28 Jan 2020. 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?

Correlation between lipid targets and an acute stroke incident (time frame: Through study completion, anticipated through to July 11, 2019.). 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 28 Jan 2020.

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