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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02389647
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : August 11, 2017
Sponsor:
Collaborators:
Translational Genomics Research Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix

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.

Condition or disease
Cerebral Ischemia

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Novel Molecular Markers for Cerebral Ischemia From Patients With Minor and Devastating Ischemic Injury
Study Start Date : March 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Group/Cohort
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.



Primary Outcome Measures :
  1. Identification of biomarkers selective for ischemia of the central nervous system [ Time Frame: After each blood draw ]

Biospecimen Retention:   Samples With DNA
Blood


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

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

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): NCT02389647


Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Translational Genomics Research Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Peter Nakaji, MD Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

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Responsible Party: Madelon Petersen, Research clinician, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02389647     History of Changes
Other Study ID Numbers: 13BN094
5UH2TR000891 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Brain Diseases
Brain Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Stroke