Neuronal and Glial Biomarkers in Stroke

NCT02409043 | Completed

• 1 other identifier: IRB201200330
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if there are molecules in the blood that indicate when a person has had a stroke, and what type of stroke they have had, so that appropriate treatment may be begun as soon as possible. This study is also being conducted to determine whether these molecules can help to predict long-term health following stroke. Some of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has activity that has been shown to be helpful cardiovascular disease and shown to be altered in animal models of acute stroke, where it is also shown to provide neuronal protection.

Conditions

Stroke

Keywords

Stroke; Ischemic stroke; Hemorrhagic stroke; Biomarkers; Angiotensins

Outcome Measures

Primary Outcomes (3)

• Acute Serum ACE2 Activity Levels

  Serum and whole blood will be analyzed for levels of ACE2 activity. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.

  Day 1

• Subacute Serum ACE2 Activity Levels

  Serum and whole blood will be analyzed for levels of ACE2 Activity.

  Day 3

• Follow-up Serum ACE2 Activity Levels

  Serum and whole blood will be analyzed for levels of ACE2 Activity. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.

  8 weeks

Secondary Outcomes (13)

• Initial NIH Stroke Scale Score

  Day 1

• Recovery NIH Stroke Scale Score

  Day 14

• Initial infarct size from brain imaging studies

  Day 1

• Recovery infarct size from brain imaging studies

  Day 14

• Initial modified Rankin Score

  Day 1

Study Arms (4)

Control

Non-stroke participants. Blood drawn for analysis of biomarkers.

Other: Blood draw

Ischemic Stroke

Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview.

Other: Stroke blood draw

Hemorrhagic Stroke

Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview.

Other: Stroke blood draw

Stroke Mimic

Participants presenting at the University of Florida Shands Emergency Department with signs and symptoms resembling a stroke, but which are determined to be from another cause. Blood drawn during initial emergency room evaluation.

Other: Blood draw

Interventions

Blood draw OTHER

Blood drawn for comparison with other groups

Control; Stroke Mimic

Stroke blood draw OTHER

Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, blood pressure, MRI infarct volumes, and hospital length of stay taken from the medical records. 3 month modified Rankin scale score collected by phone interview.

Also known as: Information collection

Hemorrhagic Stroke; Ischemic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals experiencing stroke symptoms who present at the University of Florida Shands Emergency Department or non-stroke control participants. These individuals will be invited to participate as study participants by a study representative within the first 24 hours after having a blood draw in the emergency department.

You may qualify if:

• Stroke, ischemic or hemorrhagic, is confirmed by clinical and/or imaging evidence
• For control participants, no acute or recent stroke

You may not qualify if:

• Onset of stroke symptoms cannot be confirmed to be less than 18 hours

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and packed red blood cells

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Harry Nick, PhD

  University of Florida

  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: February 2, 2015
• First Posted: April 6, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)