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

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ClinicalTrials.gov Identifier: NCT03618290
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Brief 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.

Condition or disease Intervention/treatment
Stroke, Acute Diagnostic Test: Analyze plasma free fatty acid in blood

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Free Fatty Acids Profile As A Diagnostic Tool For Acute Ischemic Stroke
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : July 11, 2019
Estimated Study Completion Date : July 11, 2019

Group/Cohort Intervention/treatment
Acute ischemic stroke group
50 patients (expected) - Acute ischemic stroke (AIS)
Diagnostic Test: Analyze plasma free fatty acid in blood

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.


Non-neurological pathologies group
25 control subjects with non-neurological pathologies (Congestive heart failure (CHF), Chronic obstructive pulmonary disease ( COPD ) etc.)
Diagnostic Test: Analyze plasma free fatty acid in blood

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.


Non AIS-related brain injuries group
25 control subjects with traumatic or other non AIS-related brain injuries. These will include: Traumatic Brain Injury (TBI), migraine, subdural hematomas or patients after neurosurgical interventions on brain tissue.
Diagnostic Test: Analyze plasma free fatty acid in blood

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.





Primary Outcome Measures :
  1. Correlation between lipid targets and an acute stroke incident [ Time Frame: Through study completion, anticipated through to July 11, 2019. ]

Biospecimen Retention:   Samples With DNA
Plasma samples in volume of 5 ml will be collected three times within a 24 hour period.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Sanford Health Fargo, ND Emergency Room for AIS with non-neurological pathologies such as CHF, COPD etc. or, with traumatic or other non AIS-related brain injuries. These will include: TBI, migraine, subdural hematomas or patients after neurosurgical interventions on brain tissue.
Criteria

This study will not involve cognitively impaired adults, children, neonates, pregnant women or prisoners.

Inclusion Criteria:

  • Have onset of stroke symptoms within 8-hours of presentation (AIS arm only).
  • 18-years old and older.
  • Able to offer informed consent after passing the MMSE with score >18.
  • 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).

Exclusion Criteria:

  • Have onset of stroke symptoms more than 8-hours before presentation.
  • Less than 18-years old.
  • MMSE score 17 or less.
  • Not able to offer informed consent due to MMSE score of 17 or less
  • If they leave the hospital within 24 hours after being admitted.
  • No longer meeting the eligibility criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618290


Contacts
Contact: Richard Lefevre, MS 605-404-4290 richard.lefevre@sanfordhealth.org

Sponsors and Collaborators
Sanford Health
Investigators
Principal Investigator: Vitaliy Starosta, MD Sanford Health

Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03618290     History of Changes
Other Study ID Numbers: SHFASt2018
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanford Health:
Acute ischemic stroke
plasma free fatty acid

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases