NCT03618290

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

July 31, 2018

Last Update Submit

January 24, 2020

Conditions

Stroke, Acute

Keywords

Acute ischemic strokeplasma free fatty acid

Outcome Measures

Primary Outcomes (1)

  • Correlation between lipid targets and an acute stroke incident

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

Study Arms (3)

Acute ischemic stroke group

50 patients (expected) - Acute ischemic stroke (AIS)

Diagnostic Test: Analyze plasma free fatty acid in blood

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

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) defined as intracranial hemorrhage or contusion.

Diagnostic Test: Analyze plasma free fatty acid in blood

Interventions

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.

Acute ischemic stroke groupNon AIS-related brain injuries groupNon-neurological pathologies group

Eligibility Criteria

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

You may qualify if:

  • Have onset of symptoms within 24-hours of presentation (AIS and Brain ?Trauma arms only).
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health

Fargo, North Dakota, 58104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples in volume of 5 ml will be collected three times within a 24 hour period.

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Vitaliy Starosta, MD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 7, 2018

Study Start

September 19, 2018

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)