Hemodynamic Effects on Cerebral Autoregulation in Acute S... | NCT02056821

Studies
Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke

NCT02056821

Sponsor

Henry Ford Health System

Status

Completed

Last Update Posted

Jan 4, 2017Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2017

Last Update Posted Date

Jan 4, 2017Estimated

Name	Class
Wayne State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cerebral blood flow velocities	Cerebral flow velocities determined by bilateral MCA measurements by TCD	initial 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Acute (< 12 hours) ischemic stroke patients presenting to the Emergency Department

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Hospital		Detroit	Michigan	48202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40012591	Derived	Miller J, Moloney JA, Elagamy N, Tuttle J, Tirgari S, Calo S, Thompson R, Nahab B, Lewandowski C, Levy P. Cerebral blood flow change with fluid resuscitation in acute ischemic stroke. Brain Circ. 2024 Dec 28;10(4):303-307. doi: 10.4103/bc.bc_30_24. eCollection 2024 Oct-Dec.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke