Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke

Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056821
• Other study ID #: A20030
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: January 2, 2017
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cerebral blood flow velocities	Cerebral flow velocities determined by bilateral MCA measurements by TCD	initial 24 hours	No