Identification of Novel Molecular Markers for Cerebral Ischemia From Patients With Minor and Devastating Ischemic Injury

NCT02389647 | Completed

• 2 other identifiers: 13BN0945UH2TR000891
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use an iatrogenic model of stroke, meaning those strokes inadvertently caused by endovascular coiling of elective aneurysms, to study the biology of stroke in humans.

Conditions

Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

• Identification of biomarkers selective for ischemia of the central nervous system

  After each blood draw

Study Arms (3)

Endovascular group

Subjects undergoing elective endovascular catheterization for coiling of unruptured cerebral aneurysms. Four blood draws of 5mL each: (1) prior to initiation of procedure; (2) at the time of catheterization of major cerebral vessels, (3) immediately after the procedure, and (4) 24-hours after the procedure.

Ischemic stroke group

Subjects who present to the emergency department with ischemic infarcts of \<6 hours. Four blood draws of 5mL each: (1) at time of enrollment but prior to tPA, (2) 6 hours post-tPA, (3) 12 hours post-tPA, and (4) 24 hours post-tPA.

Intracranial hemorrhage

Subjects who present to the emergency department with intracranial hemorrhage. One 5mL blood draw within 24 hours of onset.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to facility and diagnosed with ischemic stroke, intracranial hemorrhage, or elective endovascular coiling of unruptured aneurysm.

You may qualify if:

• Adult patients who present with ischemic infarcts to the emergency department with a known time of infarct.
• Time of infarct \<6 hours.
• Adult patients with unruptured aneurysms who present for elective endovascular coiling of the aneurysm(s).

You may not qualify if:

• Under 18 years of age.
• Patients arriving to the emergency department \>6 hours after infarct.
• Patients considered as not candidates for further care.
• Patients with ruptured cerebral aneurysm.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Translational Genomics Research Institute: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Nakaji, MD

  Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research clinician

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

US (1)