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Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke

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ClinicalTrials.gov Identifier: NCT02056821
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Wayne State University
Information provided by (Responsible Party):
Joseph Miller, MD, Henry Ford Health System

Brief Summary:
This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.

Condition or disease
Ischemic Stroke

Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016



Primary Outcome Measures :
  1. Change in cerebral blood flow velocities [ Time Frame: initial 24 hours ]
    Cerebral flow velocities determined by bilateral MCA measurements by TCD



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute (< 12 hours) ischemic stroke patients presenting to the Emergency Department
Criteria

Inclusion Criteria:

  • Suspected ischemic stroke within 12 hours of symptom onset
  • NIHSS ≥ 4
  • Age 18 to 90 years

Exclusion Criteria:

  • Baseline modified Rankin Scale > 3
  • Pregnancy
  • Intracranial hemorrhage on head CT
  • Mechanical ventilation prior to enrollment
  • Inadequate temporal windows for TCD analysis

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): NCT02056821


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Wayne State University

Responsible Party: Joseph Miller, MD, Senior Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02056821     History of Changes
Other Study ID Numbers: A20030
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Joseph Miller, MD, Henry Ford Health System:
stroke
transcranial doppler
cerebral blood flow
cardiac output
non-invasive hemodynamic monitoring

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